Live! #41 — Best Practices for Optimizing PMCF and Avoiding NB Findings

Device Advice by RQM+

This is the audio from RQM+ Live! #41, originally recorded 14 October, 2021.

Your post-market surveillance (PMS) system complying to the EU MDR was put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions!

This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and failures they’ve seen across the industry so far. While there have been and will continue to be plenty of implementation challenges, our esteemed panel has worked through comprehensive solutions and is anxious to share.

Discussion will include:

• Best practices for optimizing PMCF as it relates to the EU MDR implementation
• Typical NB findings and variations in interpretation
• Strategies to overcome audit findings and gaps in your evidence

The panel will include:

• Amie Smirthwaite, BEng, PhD - Global Vice President, Intelligence & Innovation
• Nancy J. Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
• Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
• Celeste Ann Maksim, PhD - Chief of Staff, Clinical & Post-Market Practice
• Andreas Tarnaris, M.D. MD (Res) FRCS (NeuroSur) - Medical Director

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About RQM+

RQM+ is the leading international provider of regulatory, quality and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

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