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Medical Devices Regulation Training
 
01:06:28
MedTech Europe's training on Medical Devices Regulation.
Views: 5969 MedTechEurope
The 5 most relevant changes the Medical Device Regulation MDR introduces, that  you must know
 
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The Medical Device Regulation MDR replaces both, the Medical Device Directive (MDD, 93/42/EEC) and the Directive for Active Implantable Medical Devices (AIMDD). This video gives an overview on the 5 most relevant changes the MDR introduces. These changes include 1. Conformity assessment procedures 2. Classification 3. Essential requirements - General safety and performance requirements 4. UDI & EUDAMED 5. Post-Market requirements The Johner Institute helps medical device manufacturers to fast and easily navigate the approval processes, to fulfill the MDR requirements and to obtain the CE mark. Complimentary consulting on www.johner-institute.com.
Views: 10662 Johner Institute
Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
 
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Medical Device Regulation Training - Within less than 10 minutes you'll learn how to classify a Medical Device in Europe with the new Medical Device Regulation MDR 2017/745. This step is important for the Medical Device Industry. I'll tell you How many classes it exists, why this is important. I'll also inform you about all the rules that exist and in the end, you'll have some exercises to test your knowledge. I will also provide you with a free form to download so you can be more efficient when you'll have to classify your product. Look at the notes below for the link *************************** Links ************************** - Participate to the free Mini-Course on MDR 2017/745 (6 days challenge) https://easymedicaldevice.com/mdr - Free Form to classify your medical device https://easymedicaldevice.com/class - Article on Medical Device Classification in Europe https://easymedicaldevice.com/mdclass ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice -------------------------------------------------------------------------------------------- Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 3381 Easy Medical Device
Transitioning from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR)
 
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The European Union’s Medical Device Regulation (MDR) is in place. What does it mean for device manufacturers? MasterControl and UL (Underwriters Laboratories) present a free webinar featuring industry expert Linda Chatwin, who breaks down the new regulation and offers practical tips.
Views: 13758 MasterControl
European Medical Device Market Overview
 
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Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. Interested in entering this market? This short video tells you how. Topics covered include how devices are regulated, CE Marking certification, classification of devices, the EC Rep, and more.
Views: 4387 Emergo by UL
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers
 
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Learn about the requirements for the revised MDR in Europe which will influence the work of all medical device manufacturers bringing a product to the European market.
[Webinar] Preparing for the New EU Medical Device Regulation
 
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The upcoming European Union (EU) Medical Device Regulation (MDR) will replace the Medical Devices Directive and the Active Implantable Medical Devices Directive. Travis Miller, Assent’s General Counsel, will discuss the new requirements under the regulation and what companies need to do to prepare their programs. Topics to be covered in this webinar include: - The differences between the EU MDR and the directives it will replace - Reporting requirements under the EU MDR - How to update technical documentation to comply - Which processes to implement to meet the new requirements
Views: 712 Assent Compliance
The 5 most important steps to CE certification - The EU medical device approval process
 
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This video introduces the Europan medical device regulations, in particular the Medical Device Regulation MDR, the conformity assessment procedures (sometimes referred to as "certification process") and the medical device classification. It explains when an ISO 13485 certified quality management system is required and which are the most relevant documents manufacturers have to compile You find the checklist mentioned in the video and additional information in our starter-kit: https://www.johner-institute.com/starter-kit/
Views: 5126 Johner Institute
European Medical Device Registration Chapter 2 - Classification
 
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Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. In this seven part slidecast we will demystify the process of bringing your device to market in the EU, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of October 2014. In this SlideCast: Classifying your medical device [3:36]
Views: 3679 Emergo by UL
European Medical Device Registration Chapter 1 - Overview
 
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Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. In this seven part slidecast we will demystify the process of bringing your device to market in the EU, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of October 2014. In this SlideCast: Overview of the CE Marking framework [4:40]
Views: 5479 Emergo by UL
The New Medical Device Regulation (MDR) - Webinar
 
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On 26 September 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council on medical devices and in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives (MDD, AIMD, IVD). The MDD and AIMD will be incorporated into one single regulation, the MDR. For current IVD directive, the new regulation will be the IVDR. The new Medical Device Regulation affected all kinds of medical devices, from home-use items like sticking plasters and contact lenses, to X-ray machines, pacemakers, breast implants and hip replacements. The new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices. Ensuring compliance to the new regulations is critically important for legal manufacturers in order to CE mark their devices in Europe. Manufacturers however will also benefit from clearer rules, easier trading between EU countries and a level playing field that excludes those who do not comply with the legislation. The new rules support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in this sector.
The European Medical Device New Regulation
 
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Course Description: This informative presentation outlines an initial assessment of the clinical evaluation aspects of the draft Regulation as a future substitute for the current Medical Device and Active Medical Device directives, made publically available on September 26th 2012.The main points covered are the changes in the clinical evaluation regulatory principles, followed by a gap analysis with ISO 14155 and a review of the clinical investigation process changes as proposed by the new regulation. The EU commission’s initial aim is to get parliamentary approval of this document before its new elections in 2014, which some say is very unlikely. The scope of this presentation is not so much educational, but rather a call for awareness and where needed, a reaction to the European commission while the document is up for review. Neither does this presentation give an absolute interpretation of the clinical evaluation elements in the draft regulation; instead it should be taken as a possible view of the matters which provides listeners with “food for thought”. Learn more at: http://www.wmdo.org/course-detail.aspx?id=180
Views: 618 WMDO
The New EU MDR PMS Requirements Webinar
 
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Manufacturers should expect to see a return on investment or “pay-off” when implementing the new EU MDR PMS requirements. This webinar provides practical steps for taking advantage by appropriately implementing feedback for Risk-Management as well as for Usability Engineering. The webinar provides insights as how to avoid unnecessary duplication for Post-Market Clinical follow-up if correctly aligned with PMS. The webinar will also provide a perspective upon how a PMS system interacts with other MDR requirements and provides a rational as to why the PMS requirements have been pushed into new European regulation.
Views: 852 NSF International
Medical Device QA RA recruitment situation Europe - Petra Ognjenovic
 
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► Webpage: https://podcast.easymedicaldevice.com/18 Since we have all those transitions happening in the European Medical Device regulations, I wanted to understand the situation in the recruitment market. I contacted Petra Ognjenovic from SciPro Global to help us have a better view. She is leading the life science department of the DACH region which are the acronyms of Deutschland (Germany), Austria and Switzerland (Confederation Helvetique). We will talk mainly about the European Union situation for the Quality and Regulatory affairs people. She really provided great information as I was also not aware of the situation. ► About Petra Ognjenovic Hello, I am Petra Ognjenovic, a Life Sciences recruitment specialist. I was born in the Netherlands, my parents are both Croatian and I grew up in Munich, Germany. I studied two Masters Degrees in Human Resources Education & Management and Philosophy, Psychology & Economics; Following my graduation, I was approached by SciPro, a leading recruitment business in the Life Sciences industry, and offered the opportunity to be responsible for the DACH Region within medical devices. I think that we have a huge responsibility within our industry and I am very happy that I have joined an international recruitment company full of very talented and passionate people, who, through our global network, are able to find the best talent in the market for our customers. We are fundamentaly, a people business and we love to give back to our communities. This year, we have partnered with Designability, a medical devices charity organization. Designability create innovative medical devices to help people living with disabilities to have a better quality of life. This year, SciPro will be raising money to fund our own ‘Wizzybug’ a mobility device designed for disabled children under 5. For further information please follow this Link: https://www.sciproglobal.com/csr One thing is for sure, I love my job and I love my industry so I am happy to be here today to share some insights, from the perspective of a recruitment consultant, within the Medical Devices Industry, during the MDR transition period. -------------------------------------------------------------------------------------------- ► Links from the Video ■ Petra Linkedin Profile: https://www.linkedin.com/in/petra-ognjenovic ■ SciPro Global: http://www.sciproglobal.com ■ Episode 10 – Qunique with Angelina Hakim: https://podcast.easymedicaldevice.com/10 ■ Video – Quality cost too much: https://easymedicaldevice.com/quality_cost_too_much ■ Article Human resources and the Resource Based View of the Firm: https://digitalcommons.ilr.cornell.edu/cgi/viewcontent.cgi?article=1065&context=cahrswp ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #podcast #medicaldevice #compliance
Views: 213 Easy Medical Device
Medical Device Usability: Highlights of European Regulations and the Latest Standards
 
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Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can lead to severe harm to the patients. What process is in place to limit these failures and are these avoidable? Usability Standards (IEC 62366:2007, IEC 62366:2007+A1:2014, IEC 62366-1:2015, IEC 62366-2:2016) specifies a process for analysis, design, verification and validation of usability throughout the design and development cycle of medical devices to mitigate risked caused use/user error and poor interface design. Medical device manufacturers marketing in Europe may apply Usability standards in order to demonstrate compliance with essential requirements of the European Medical Device Directives (MDD 93/42/EEC, IVD 98/79/EC) as well as in near future the new Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR). This webinar discuss Usability Engineering Process, its link to Risk management and Quality management system and highlights European requirements: - Usability - Usability and European Regulations and Standards - Overview of Usability Standards and the latest changes - Usability and Medical Device QMS
Views: 2523 GMED
The new EU Medical Device Regulation EU MDR 2017/745 with Monir El Azzouzi
 
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Welcome to this episode of Medical Device made Easy Podcast with Monir El Azzouzi. Today you´ll learn all about the new EU Medical Device Regulation. From its origin to how to implement it. If you want to participate in a Free Mini-Course on the new EU MDR 2017/745, don´t hesitate to learn more here. Within this episode I will explain to you: - The origin of the new Medical Device Regulation - The transition period - A summary of the changes - How to implement this change ---------------------------------------- Alexa Skill ---------------------------------------- I just created an Alexa Skill that you can download with the link below, on the resource section of this episode. This skill is called “How Many Days”. You can download it on your Alexa Account by clicking on the link. To activate it you need to say: - "Alexa Open How Many Days" - "Alexa, ask How Many Days until the new Medical Device Regulation" I know this is more a gadget but I will create more sophisticated ones. Just give me some time. -------------------------- Subscribe on the different platforms -------------- Don´t forget to subscribe to this podcast to be informed when new episodes are released. And don´t forget to rate and review. This is important to be able to spread the word. - Link: https://podcast.easymedicaldevice.com ----------------------------------------- Resource ------------------------------------------ - Subscribe to the Free Mini-Course MDR 2017/745: https://easymedicaldevice.com/mdr - MDR 2017/745 Transition Timeline blog post: https://easymedicaldevice.com/mdr-transition/ - Alexa Skill: How Many Days until the new Medical Device Regulation: http://a.co/0RXz5zp ----------------------------------------- Social Media -------------------------------------- - Linkedin: https://easymedicaldevice.com/linkedin - Twitter: https://easymedicaldevice.com/twitter - Pinterest: https://easymedicaldevice.com/pinterest - Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance
Views: 679 Easy Medical Device
The European Medical Device New Regulation 2017/745
 
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Course Description: This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics: Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities) Structure of the EU MDR and other related regulations Definition and classification of medical devices (MEDDEV 2.4/1 Rev 9) Conformity assessment procedures and routes Quality system requirements General safety and performance requirements in Annex I and the use of harmonized standards Clinical evaluations, including references to MEDDEV 2.7.1/Rev 4 and clinical investigations Technical file and design dossier requirements Medical device vigilance Designation and oversight of notified bodies by the Medical Device Coordination Group (to be released in Q1 2019) UDI-DI requirements in Annex VI (to be released in Q1 2019) Learn more at: https://wmdo.org/course-detail.aspx?id=180
Views: 306 WMDO
BSI expert talks about the transition to the EU Medical Device Regulations
 
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Understanding and planning your transition to the new regulations is key to ensuring compliance for your medical devices. Kevin Madden, BSI Medical Device Product Specialist, shares his expertise at Medical Technology Ireland about the transition to the EU Medical Device Regulations. Follow Compliance Navigator Medical Device Blog and stay up to date with the new Medical Devices / IVD Regulations and innovations in the medical device industry. https://compliancenavigator.bsigroup.com/en/community/blog-page/
Views: 1981 BSI Group
What Is a Medical Device? (New Medical Device Regulation MDR 2017/745)
 
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Medical Device Regulation Training - What is a Medical Device in Europe? The new Medical Device Regulation EU MDR 2017/745 change the definition of a Medical Device. Now there is more clarity in terms of some additional functions, products. Bonus: I will also share with you the new products on the scope of the Medical Device Regulation even if they have no Medical Purpose. -------------------------------------------------------------------------------------------- Article: "Definition: What is a Medical Device?" https://easymedicaldevice.com/2018/03/medical-device-definition/ Free Mini-Course MDR 2017/745 - https://easymedicaldevice.com/resource-medical-device-regulation/mini-course-mdr/ If you really want to test if your product is a Medical Device, use our free tool. https://easymedicaldevice.com/is-my-product-a-medical-device/ -------------------------------------------------------------------------------------------- Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevices/ Instagram: https://www.instagram.com/easymedicaldevice/ Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 1828 Easy Medical Device
Post Market Surveillance requirements under the new European Medical Device Regulations
 
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In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action requiring Medical Device Manufacturers to “proactively collect and review experience gained from their devices placed on the market.” With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the process is at the very heart of this change, the Regulations introduces more incisive and prescriptive measures based on device risk level for both the MDR and IVDR. While Post Market Surveillance was always a regulatory requirement, the new measures introduced require that manufacturers follow on specific directions, tightening the links between PMS activities and other processes. Few examples of these new measures are: the issuance of Periodic Safety Update Reports (PSURs) to Notified Bodies, the update of the Vigilance and PMS procedures per the new requirements, and the increased involvement of Notified Bodies and authorities in the process.
Views: 3939 GMED
TÜV SÜD E-ssentials: The new European Union Medical Device Regulation MDR
 
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Summary of the most relevant changes of the new European Medical Device Regulation.
Views: 603 TÜV SÜD AG
Introduction to Drug-Device Combination Regulations in Europe
 
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Course Description: This course provides an in depth review of the European regulations covering drug device or device drug combination products, and it specifies which directives are applicable and how their interrelationship for combination products should be considered. The involvement of notified bodies and interactions with regulatory authorities and EMEA are specified, with guidance given on how to approach different types of borderline situations. Learn more at: http://www.wmdo.org//course-detail.aspx?id=160
Views: 386 WMDO
Implementing the New European Medical Devices Regulations
 
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Asphalion is hosting an advanced introduction and insight in the new challenging environment of EU. During this informative session, we will cover hot topics such as: • Upcoming changes in medical devices development and commercialization (new and clarified pre-market and post-market requirements) • Updated implementation deadlines and latest news • Impact on the daily activities of medical devices companies • In addition, we will give advice on how to start planning implementation activities and the main steps for recertification.
Views: 301 Asphalion
How to prepare for the changes to OEM medical devices under the new MDR
 
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Learn how to prepare for the changes to OEM Medical devices under the new Medical Device Regulation (MDR). Prior to the MDR is was possible to market devices as a Private Label Manufacturer (PLM) without disclosing the Original Equipment Manufacturer (OEM). This is not possible under the new MDR.
Views: 901 NSF International
Recent EU Medical Device Regulatory Evolutions: Moving Forward
 
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In June 2015, the EU Council published a set of revisions to the EU medical devices and IVD regulatory proposals, originally published in 2012 by the EU Commission. As the regulatory process moves forward, medical device manufacturers wait for the updated regulations to analyze on how to absorb important points like conformity assessments and reclassifications. The compromise documents that were published in June take medical device manufacturers another step forward in the process of understanding their evolving regulatory requirements. The webinar will cover topics like: Reclassifications and regulatory scope expansions, Conformity assessment changes proposed in the documents, and What the next steps are in the process.
Views: 1199 GMED
Medical devices: Better regulation for Europe
 
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French breast implant manufacturer PIP's decision to put dangerous gels in their products is one example of recent scandals involving medical devices. The European Parliament wants greater scrutiny on the industry. New legislation enforces stricter regulation and encourages innovation. In vitro diagnostic medical devices lead to better treatment and improve the health of EU citizens. Comment on: Google + http://tinyurl.com/orh99s6 Facebook http://www.facebook.com/europeanparliament Twitter https://twitter.com/Europarl_EN
Views: 1387 European Parliament
FDA Regulation of Medical Devices (Part 1 of 3)
 
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(Part 1 of 3) General overview of medical device regulation.
EU Medical Device Regulation: Your Questions Answered
 
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With the European Union (EU)’s new Medical Device Regulation (MDR) taking effect in May 2020, device manufacturers transitioning to the EU MDR face a host of questions. Among them are: -Is it possible to avoid compliance with the MDR? -When should I be compliant? -How will this affect my new product development? -How does this affect my products currently on the market? -Which notified body should I use? -How will Brexit affect my company? -Where do I begin? This webinar will address these and other critical questions and will pave the way to strategic planning for compliance with the EU MDR. New product development teams will discover that the timeline for MDR is extremely limited compared to existing products on the market. Post-market surveillance teams will discover the implications of the Post-Market Clinical Follow-up requirement and the European Database on Medical Devices. In this webinar, our featured speakers will review the importance of: -Having a robust regulatory strategy -Conducting a gap analysis of current technical documents and -products -Investing in budgetary and human resources -Communicating with your Notified Body Adopting to MDR within the allotted regulatory timelines
Views: 106 Premier Research
What Is the European Union Medical Device Regulation?
 
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On May 26, 2020, the European Union (EU) Medical Device Regulation (MDR) will come into effect — but many companies may not understand what it is or what is required of them. In this video, you will learn: - What is the EU MDR - How in-scope companies are affected - The risks associated with non-compliance - What companies must do to achieve compliance - And more! Assent helps companies efficiently collect, centralize and manage their data through the Assent Compliance Platform, supporting compliance with regulations such as the EU MDR. Contact us today to learn more.
Views: 66 Assent Compliance
Medical Device Webinar: Key EU and US regulatory changes on the horizon
 
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Join Amanda Maxwell, Regulatory Affairs Editor, David Filmore, Executive Editor, and Ashley Yeo, Principal Analyst as they will focus on medtech regulation and the key changes that are likely to impact the industry in the coming months/years; - US regulatory market overview, including a look at the shift in focus of the FDA as well as improvements made in their efficiency. - Key points of evolution to expect in the US; exploring real-world data and it’s uses, nascent regulatory mechanisms and changes in IVDs. - User fee reauthorization and key outputs. - EU regulatory overview, including current directives, new regulations for devices and IVDs and the key regulatory players - Key EU regulatory changes and how manufacturers must prepare, across medical device regulation and IVD regulation - Dalli Plan of Joint Actions - An update on the UK and Brexit
The future of medical device regulation in the European Union – EuroPCR 2019
 
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New EU regulations on medical devices will come into force in 2020. Robert Byrne and Paul Piscoi explain how new regulation is needed “to reflect the changes in the field over the last decades” and outline what this will mean for the safety of medical devices. What are the most important issues contained in the regulation and how will sufficient clinical evidence for medical devices be measured? How can physicians become involved in the work of expert panels and how do they contribute to medical device regulation? The content of this video was filmed at #EuroPCR 2019, see more videos here: https://www.pcronline.com/Cases-resources-images/Resources/Educational-interviews
Views: 131 PCR
Enhance your knowledge of the New EU Medical Device and In Vitro Diagnostic Device Regulations
 
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To assist medical device and in vitro diagnostic device manufacturers with the complexity of the new regulations, SGS developed MDR and IVDR eLearning courses. Learn more here: https://www.sgs.com/MDR-IVDReLearning.
Views: 684 SGS
RegDesk Webinar: EU New Medical Device and IVD regulations
 
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The new EU Medical Device and IVD Regulations will affect all stakeholders including manufacturers, importers, and distributors. Listening to this conversation with Dr. Christian Huyghe, who has been in the life sciences industry for over 30 years, will give you a deeper understanding of the changes and how it will impact your business. Please share your feedback on this video and topics that you want us to cover in future webinars: https://goo.gl/forms/0AhYKOxHKWsjWDYz1 If you have questions specific to your product with respect to the EMA or any other regulatory agency worldwide, please contact us at: [email protected] Subscribe to our YouTube channel for more regulatory insights. Check out our website: http://regdesk.co Follow us on: Facebook: https://www.facebook.com/regdeskinc/ Twitter: https://twitter.com/RegDesk Linkedin: https://www.linkedin.com/company-beta/5136289/
Views: 706 RegDesk
Webinar (Feb 2017): Postmarket Compliance - ISO 13485:2016 & New European Medical Device Regulations
 
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There’s so much change going on right now, with the upgrade to ISO 13485:2016 and the transition to the new European regulations creating headaches for us all. What is notable about all of this is how much of the change is now focused on the postmarket world – i.e. requirements to ensure continuing compliance and safety once the product is approved for marketing. For sure there are updates to document requirements for conformity assessment, but the biggest changes in both ISO 13485 and the EC Regulation are all about active vigilance. It’s no longer enough to just keep a weather eye on customer complaints. Join Arthur Brandwood, Principle Consultant to take a closer look at the changes in the upgrade to ISO 13485:2016 and the transition to the new European regulations.
Views: 2082 Brandwood Biomedical
An Introduction to the European Regulatory Process for Medical Devices
 
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Quality First International (QFI) - a leading, global medical device regulatory consultancy - is pleased to provide an introduction to the European medical device regulations. www.qualityfirstint.com
Views: 2223 qualityfirstint
What is a European Authorized Representative (EU MDR 2017/745)
 
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What is a European Authorized Representative or EC Rep or CE Representative? (EU Medical Device Regulation MDR 2017/745) This is an important topic for the Medical Device Industry. There are many names for this Economic Operator that is required if you are a Medical Device Manufacturer located outside of the European Union. Learn within this video who can be an EC Rep and what are its responsibility. You'll see that after that you'll maybe not want to become an EC Rep. Is it enough to have an Authorised Representative to sell your medical devices in Europe? No, there are still some economic operators that you need. Let's see together which one it is. It's also important to know why your distributor is not the right choice for being your EC Rep. Yes, I know that it would be easier for you to have 1 entity to do both but you'll see that there will be a lot of risks. On my Article "Top 11 questions about the European Authorized Representative I inform you about how to choose one and also about the Brexit. Because all the E.A.R. located in the UK will lose this qualification as the UK is leaving the European Union. But maybe they'll be on the EFTA as Switzerland. I hope this video helps you to understand more about this Economic Operator role. -------------------------------------------------------------------------------------------- Links from the Video - Resource page: https://easymedicaldevice.com/links - Top 11 questions on the E.A.R: https://easymedicaldevice.com/ec-authorized-representative/ - Free Mini-Course EU MDR 2017/745: https://easymedicaldevice.com/mdr ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedical... Instagram: https://www.instagram.com/easymedical... ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance
Views: 836 Easy Medical Device
Future of Clinical Data and Medical Device Regulation 2017/745
 
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For questions about this topic, please contact [email protected] This presentation provides an overview of the new requirements of Medical Device Regulation 2017/745 as well as of the MEDDEV 2.7/1 Rev. 4 regarding clinical evaluations. Sandra Bugler, M.Sc. provides insights into the conduction of a clinical evaluation. Learn about the: Interpretation of new requirements Structure of clinical evaluation reports Challenges regarding equivalent devices Clinical data for class III and implantable devices Post-Market Clinical Follow-up
Views: 1519 NSF International
ECMDR European Course of Medical Device Regulation
 
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ECMDR is the first integrated European Diploma Course of Medical Device Regulation on the ECPM Training Platform at the University of Basel. It incorporates all essential aspects of medical device technology and their regulation in Europe and internationally. Mission ECMDR was created to provide a training platform in Europe to enhance the knowledge, expertise and skills needed to accompany and support: -- certified and comprehensive education on integrated cutting-edge concepts and best practices leading to appropriate use of medical devices and their combinations, e.g. pharmaceuticals as well as in vitro diagnostics and companion diagnostics -- development, manufacture, installation and post-production vigilance as set out and regulated by medical device legislation, -- implementation of administrative guidelines and other guidance applicable in Europe --integrated product development which is science-based, efficient, economical and of high quality Title and Credit Points The ECMDR is presented as a self-standing programme of 6 Modules of 4 days each to obtain the Diploma in Medical Device Regulation offered by the European Center of Pharmaceutical Medicine (ECPM) and is accredited with 30 ECTS by the University of Basel in collaboration with the European So-ciety of Medical Device Regulation (ESMDR), DIA Europe and the Regulatory Affairs Professionals Society (RAPS).
Views: 329 ECMDRBasel
Webinar (May 2016): Medical Device Regulations in Australia
 
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Australia continues to be an attractive medical device market. It is sophisticated, transparent and for implantable devices there are reimbursement schemes that deliver certainty of pricing. The national regulator continues to improve processes to streamline registration of medium to low risk produces based on European (CE) certification evidence, although there's some way to go on dealing with backlogs of technical file desk audits ("application Audits") for certain higher risk devices. TGA continues to update the regulatory framework, with a current consultation on a key guidance for clinical evidence requirements, a new notification scheme for custom made devices and participation in the MDSAP program - which provides opportunities for faster registrations in Australia. If you're looking to enter the Australian market for the first time - or are already active and need a refresher - this Webinar will provide an up to the minute overview of the Australian regulatory system and current issues.
UDI and the EU MDR What You Need to Know to Comply
 
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Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about the UDI aspects of the new EU Medical Device Regulation (EU MDR) in this free webinar. Learn about: EU MDR Summary and Timelines EU MDR Labeling & Data Requirements Details UDI Labeling & Data Lessons Learned in US and Application to EU
Views: 422 PRISYM ID
MDR Medical Device Regulation and CE Marking Webinar
 
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On 5th April 2017, the European Parliament voted to adopt the long-awaited Medical Device Regulation (MDR) The MDR regulation will replace the current medical device directive (MDD) and the active implantable medical device directive (AIMD). In this Webinar, we will focus on key changes of MDR and Transition Period Key talking points • Key Changes in New Medical Device Regulation (MDR) • CE Marking Process • MDR and Transition Period This webinar will help you to consider necessary action required to be prepared for the change in requirements of standard as well as planning of CE Marking.
Views: 628 stanley yeo
Reclassification of Medical Devices, upcoming revisions of EU regulations
 
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Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not being the final version, the position of the EU Council provides some insight and a better understanding of the regulation to be discussed by the “Constitutional Triangle” composed of the EU Commission, Parliament and Council. The final adoption of the new regulation is expected to significantly revamp the current EU Directives regulating Medical devices (MD) and In vitro Diagnostics (IVD). In this webinar, we will analyze the positions of the three main actors (EU Commission / Parliament / Council), focusing on the potential changes affecting the classification of MD and IVD devices. The topics covered in this webinar include: - The state of the EU regulations and the processes it entails - The evolution of the EU regulations - Possible classification changes and the corresponding pathway for CE Marking - Potential impacts for MD and IVD manufacturers
Views: 897 GMED
Part 1: Medical Device Regulations
 
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Part 1: Medical Device Regulations John Simon, ASQ Certified Quality Auditor ACAMP Seminar: Health & Medical 2009 www.acamp.ca
Views: 5615 acampalberta
The New Medical Device Regulation (MDR) - Webinar
 
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Record of a webinar on the new MDR, hold by Dr Bassil Akra on 28 June 2017. On 26 September 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council on medical devices and . The European Unions Medical Device Regulation (MDR) is in place. What does it mean for device manufacturers? MasterControl and UL (Underwriters . Theres so much change going on right now, with the upgrade to ISO 13485:2016 and the transition to the new European regulations creating headaches for us .
Views: 974 Stoicunexist
Webinar | Medical Devices Regulation – Heading in the right direction?
 
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This webinar from HCWH Europe covers the provisions laid out in the Health Technology Assessment and how they relate to the MDR. This webinar outlines the current regulatory framework applicable to medical devices, including the state of the European Database on Medical Devices (EUDAMED), which is due to become operational in 2019. Oliver Bisazza from industry association MedTech Europe addresses the challenges, concerns, and opportunities that the new MDR represents for the industry. Whilst Tomas Delimon representing Zorgnet-Icuro, the Flemish healthcare provider and HCWH Europe member, outlines the approach they are taking to incorporate environmental sustainability, as well as quality and safety concerns in their medical devices procurement. Read more: www.bit.ly/2OaLDdw
New Medical Device Regulations Published
 
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Short announcement about the publication of the new Medical Devices Regulation 2017/745 and In Vitro Diagnostics Regulation 2017/746.
Views: 264 cemarking.net
ECMDR European Course of Medical Device Regulation
 
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ECMDR is the first integrated European Diploma Course of Medical Device Regulation on the ECPM Training Platform at the University of Basel. It incorporates all essential aspects of medical device technology and their regulation in Europe and internationally. Mission ECMDR was created to provide a training platform in Europe to enhance the knowledge, expertise and skills needed to accompany and support: -- certified and comprehensive education on integrated cutting-edge concepts and best practices leading to appropriate use of medical devices and their combinations, e.g. pharmaceuticals as well as in vitro diagnostics and companion diagnostics -- development, manufacture, installation and post-production vigilance as set out and regulated by medical device legislation, -- implementation of administrative guidelines and other guidance applicable in Europe --integrated product development which is science-based, efficient, economical and of high quality Title and Credit Points The ECMDR is presented as a self-standing programme of 6 Modules of 4 days each to obtain the Diploma in Medical Device Regulation offered by the European Center of Pharmaceutical Medicine (ECPM) and is accredited with 30 ECTS by the University of Basel in collaboration with the European So-ciety of Medical Device Regulation (ESMDR), DIA Europe and the Regulatory Affairs Professionals Society (RAPS).
Views: 340 ECMDRBasel
Labeling Requirements for Medical Devices in Europe
 
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Course Description: This course provides a comprehensive review of the European labeling requirements outlined in directives 93/42/EEC (Medical Device Directive [MDD]) and 90/385/EEC (Active Implantable Medical Device Directive [AIMDD]), as well as the requirements in harmonized standards EN 980, EN 1041, and ISO 15223. This course also offers detailed guidance on how to apply regulations and requirements, as supported by examples of labeling development for medical devices in the European market. Learn more at: http://www.wmdo.org/course-detail.aspx?id=133
Views: 591 WMDO
What means "Placing on the market"? (CE mark Medical Device)
 
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What does it mean to place a product on the market for a Medical Device? [Download Powerpoint Slides - Link below] I try to answer this question as it's not easy to understand the difference when a product is still under the manufacturing control and the product is under the distributor control. This is a critical question for the Medical Device Industry. I use the Medical Device Regulation EU MDR 2017/745 and the blue guide as a reference to provide you the answer to it. There are 3 definitions that are important for a better understanding: - Placing on the market - Making available on the market - Putting into service I show you what is the connection between those 3 definitions. Maybe you ask yourself why is this so important. On the new MDR 2017/745 on Article 120 paragraph 4, there is a sentence saying: "Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025." So for your business survival, this definition is key. If you don't place your product on the market before May 26th, 2020, then they can be lost and the only choice you'll have will be to scrap them. Let me know in the comment if this is really helping you. ---------------------------------------------------------------------------------- Links from the Video - Blog Post: https://easymedicaldevice.com/mdr-transition - EU MDR 2017/745 & Blue Guide (EUROPE): https://easymedicaldevice.com/resource-medical-device-regulation/ - Presentation slides: https://mailchi.mp/f29ec4a61e77/placing-on-the-market ---------------------------------------------------------------------------------- Social Media to follow - Linkedin: https://easymedicaldevice.com/linkedin - Twitter (Monir): https://twitter.com/elazzouzim - Twitter (Easy Medical Device): https://easymedicaldevice.com/twitter - Pinterest: https://easymedicaldevice.com/pinterest - Instagram: https://www.instagram.com/easymedicaldevice - Youtube channel: https://easymedicaldevice.com/youtube ---------------------------------------------------------------------------------- #medtech #medicaldevice #compliance
Views: 434 Easy Medical Device
European Medical Device Registration Chapter 3 - Quality Management System
 
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Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. In this seven part slidecast we will demystify the process of bringing your device to market in the EU, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of October 2014. In this SlideCast: QMS requirements [2:19]
Views: 2554 Emergo by UL