Implementing Clinical and Performance Evaluation Reports for Your Medical Device – Webinar Recording/Transcript
Implementing Clinical and Performance Evaluation Reports for Your Medical Device: Best Practices for Getting them Right
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Think you and your team are off the hook because medical device directive (MDD) certificates are being maintained for additional time in the EU? This extra leeway afforded won’t solve the ultimate issue: the bar for demonstrating safety and medical device performance has been raised.
Notified bodies (NBs) are now more strictly enforcing clinical and performance evaluation requirements. If you want to obtain or maintain a CE Mark and you’d like to sell or distribute your devices in the EU, you must meet the requirements of the Medical Device Regulation (EU-MDR) and/or In-vitro Diagnostic Device Regulation (EU-IVDR). To prepare for these complex changes, which will take place in May 2021, you and your team will be best served by assessing and shifting your processes and procedures as soon as possible.
In this FDAnews presentation, Jon Gimbel, Ph.D., an executive director at Regulatory and Quality Solutions, will explain what you must know to meet EU-MDR’s and EU-IVDR’s requirements, how to understand clinical and performance evaluation reports and how to proceed through these new expectations.
Key Presentation Takeaways:
- An understanding of EU-MDR requirements for clinical evaluations and IVDR performance evaluations, including necessary evaluation plans and reports
- Ideas for recommended CER and PER structures
- How literature searches can be used within these evaluations
- An understanding of common NB findings and pitfalls, including those related to equivalence and measurable objectives
- Strategies for overcoming common NB findings and pitfalls, including properly justifying equivalence and data presentation
This presentation will guide you to a deeper understanding of what your company must do to meet the EU-MDR and EU-IVDR requirements, how to manage any necessary adjustments and how to get ahead of any potential issues.
Ensure your CE Mark success.
Meet Your Presenter:
Jon Gimbel, an executive director at Regulatory and Quality Solutions, has a Ph.D. in mechanical engineering and more than 20 years of experience with medical devices. He has completed regulatory and quality work with companies small and large and has been involved in over 100 CERs. Dr. Gimbel is now using his experience to help companies with performance evaluations and has an indepth understanding of how notified bodies review these evaluations.
Who Will Benefit:
- Quality managers
- Regulatory managers
- Operations managers
- Design managers
- Technical managers
- Clinical managers
- Authorized representatives in Europe