EU-MDR: Are You Ready? An Exclusive Three-Part FDAnews Webinar Series – Webinar Recording/Transcript
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EU-MDR: Are You Ready?
An Exclusive Three-Part FDAnews Webinar Series
The EU-MDR compliance clock is ticking. Your legacy products marketed in the EU are at serious risk unless you act now. Many devicemakers still aren’t ready. The transition is one complicated set of rules!
FDAnews has put together an exclusive three-part webinar series to help you get ready:
Part I: The Real Role of the Person Responsible for Regulatory Readiness & Compliance
Purchase as a Webinar Recording/Transcript. Recorded on Thursday, Feb. 20, 2020.
- Find out why a PRRC is required in the first place and what is the PRRC duties and responsibilities
- Determine whether the PRRC is over or under qualified or unable to fulfil their duties due to tasks overload
- Get a sense of the relationship between the PRRC and the strategy set for regulatory compliance
- Discover how the processes of a medical device manufacturer and other economic operators should be planned in order to fulfil the requirements for a PRRC
- Critically evaluate whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance
- Familiarize yourself with the importance of organizational design to ensure the various roles participating in compliance are understood and coordinated
Part II: Tips for Assessing Your Readiness Prior to Notified Body Review
Friday, April 10, 2020, 11:00 a.m. - 12:30 p.m. EDT
- Audit the Quality Management System (QMS) elements in Article 10
- Review of the Annex II technical documentation supported by Annex I and Annex III
- Understand the requirements for the Annex IX application
- Recap the notified body document review in Annex VII
- Understand the notified body audit based on Annex VII
Part III: Ensuring Your Postmarket Surveillance Readiness
Thursday, April 23, 2020, 1:30 p.m. - 3:00 p.m. EDT
- How to prepare your PMS plan
- How to prepare other related plans — the complaint management plan, the trend report plan and if applicable, the PMCF plan
- How to determine the reports required for the PMS System
- How to determine when to prepare a PMCF plan
- Understand the content of the PMCF Evaluation Report
- How to link PMS data and PMCF data to risk management
Ensure your EU-MDR readiness. Register today to join us for the exclusive three-part webinar series.
Who Will Benefit
- Quality Managers/Engineers
- Risk Managers
- Regulatory Affairs
- Design Engineers
- Supply Chain Managers
- Production Managers/Engineers
- Document Control Specialists
- Marketing Managers
- Clinical Managers
- Clinical Evaluation Specialists
- Export Compliance Managers