Episode description
This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021.
The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:
- No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done correctly
- No, you should not start calling your medical device software not a medical device to avoid compliance
- No, you should not ignore your non-medical accessory software that's part of your system when implementing the MDR. The notified bodies are not letting this pass.
- No, you should not start with a weak PMS plan to enable hitting the target date with an intention to revise before your next surveillance audit.
The above strategies can put your company's CE marking and reputation with the notified body in serious jeopardy. However, there are effective strategies for staying on the market as long as possible while also remaining compliant. Please join our former notified body leaders and regulatory subject matter experts for an informative discussion and bring your questions and ideas!
Panelists:
- Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Felicia Hosey, RAC - Senior Principal Specialist
- Brian Hockett - Principal Engineer
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About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.