Webinar: Webinar One: Demystifying EU MDR: Navigating Compliance Challenges and Achieving CE Certification by Elsevier

Webinar One: Demystifying EU MDR: Navigating Compliance Challenges and Achieving CE Certification

About

The EU Medical Device Regulation (EU MDR) has posed significant challenges for both novice and seasoned Quality Assurance and Regulatory Affairs (QA/RA) professionals since its inception.

Join us for an insightful webinar that will provide you with a roadmap to begin your journey, emphasize its importance, and equip you with the knowledge to avoid common pitfalls.

In this session, we will guide you through the fundamental aspects of EU MDR, empowering you to help your organization obtain CE certification, whether it's for the first time or recertification. Gain a high-level understanding of the regulations and requirements governing medical device development in the EU, including the MDR, Guidance Documents, and the State-of-the-Art (SOTA) principle.

Our expert speakers will walk you through:

critical components of technical documentation

outline best practices for conformity assessments

explore current timelines and milestone management to ensure you stay on track with compliance obligations

Drawing from real-world experiences, we will discuss common pitfalls encountered by organizations during their EU MDR journey and share valuable lessons learned.
Finally, a panel of experts will address your burning questions during an engaging Q&A session.

Part of the Cracking the Code: Demystifying EU MDR and IVDR Compliance webinar series:

Webinar Two: Navigating the IVDR Maze: From CE Certification to IVD Device Registration

Webinar Three: How to pass your Clinical Evaluation Assessment Report (CEAR): Creating a pragmatic systematic literature review process to assure EU MDR approval

When

Thursday, July 13, 2023 · 11:00 a.m. Eastern Time (US & Canada) (GMT -4:00)

Agenda

Medical Device Development in the EU
Applicable Regulations & Requirements (MDR, Guidance Documents, SOTA)
Technical Documentation
Conformity Assessments
Current Timelines & Milestone Management
Pitfalls and Lessons Learned
Q&A with Panelists

Presenters

Ben Bancroft

Medical Device Guru II, Guru Services

Benjamin Bancroft is a Senior Medical Device Guru at Greenlight Guru who enjoys working on audits, CAPAs and Root Cause Analysis. He is a Quality and Regulatory Manager who began his career maintaining the QMS for multiple companies as a CAPA and audit SME. He enjoys helping customers successfully navigate regulations to help achieve compliance and aim towards industry best practices for their devices.

Bijan Elahi

Award winning Medical Device Risk Mgmt author, educator and consultant

Bijan Elahi has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he is also teaching a graduate course on medical device risk management at Drexel University (Philadelphia, USA).
Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 8,000 individuals worldwide with outstanding results. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

Julie Brent

Elsevier, Customer Consultant Life Sciences

Julie Brent has a BS degree in Biology from the University of Albany. She has spent the last 30 years helping scientists further their research, initially supporting benchtop research and now supporting literature searching and review for regulatory requirements, informing clinical decisions and scientific discovery.

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