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 for May 2020 set date. 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
Thursday, Feb. 20, 2020, 1:30 p.m. - 3:00 p.m. EST
- 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
Thursday, March 26, 2020, 1:30 p.m. - 3:00 p.m. EDT
- Ensure your strategy for regulatory compliance has been implemented and enables technical documentation to be up to date and compliant
- Implement strategies to review your technical documentation to ensure regulatory requirements and the GSPR’s are addressed
- Understand how a product review is undertaken by a notified body
Part III: After May 2020, Ensuring Your Post-Market Surveillance Readiness via a Risk Management Framework
Thursday, April 23, 2020, 1:30 p.m. - 3:00 p.m. EDT
- Understand the essential links between risk management, clinical evaluation, post-market surveillance and post-market clinical follow-up
- Determine the difference between generating and gathering clinical data
- Establish and assess systems for trending in accordance with article 88
- Discover the difference between reactive and proactive post-market surveillance
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