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October 2022

03 October - 04 October

Sponsored By:

4th Annual European Medical Device & Diagnostic Post-Market Proactive Surveillance & Vigilance Conference

Brussels, Belgium

Amie Smirthwaite, BEng, Ph.D. – RQM+ Senior Vice President, Intelligence & Innovation

Stop by our booth to visit the RQM+ team and don't miss our speaking session, ‘What is “proactive” PMS and how can you ensure compliance under EU MDR & IVDR?’ and our roundtable discussion on the topic of continuous benefit-risk assessment.

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13 October

11:00 AM - 12:00 PM ET | 5:00 PM - 6:00 PM CET

Presented By:

RQM+ Live! #61 — Medical Device Software: Top Deficiencies and Requests for Additional Info from FDA and Notified Bodies

Virtual Event

Nancy Morrison, RAC, VP, Intelligence & Innovation
Allison Komiyama, Ph.D., RAC President, AcKRS\ntelligence & Innovation - IVD
Kevin Go, RAC Project Engineer

This RQM+ Live! show will touch on anything discussed at this year's RAPS Convergence. Nothing is off-limits! We'll cover the key highlights from each of our speaker's sessions, including: Clinical evaluation, recent developments in EU regulations (MDR and IVDR), post-market clinical follow-up (PMCF) and risk management, developing IVDR-compliant intended purpose statements that serve the business and meet notified body expectations, and how to efficiently prepare your eSTAR submission.

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17 October - 18 October

Presented By:

TOPRA Medical Devices / IVDs Symposium 2022

Vienna, Austria

Heike Moehlig-Zuttermeister, Ph.D., RQM+ VP Intelligence and Innovation, IVD

Join Heike's panel discussion during this conference on the 19th of October during the session " IVD2: Clinical performance studies under IVDR".

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November 2022

08 November

10:00 AM - 11:00 AM ET | 4:00 PM - 5:00 PM CET

Presented By:

Webinar: Common FDA and Notified Body Software Deficiencies and How to Avoid Them

Virtual Event

Nancy Morrison, RAC - VP, Intelligence & Innovation
Ashley (Ash) Clark, MS, RAC - U.S. and Medical Device Principal Specialist

Notified bodies and the FDA expect to see complete software documentation, but things like inconsistency in the risk classification, failure to follow the most current or active guidance, or inadequate clinical evidence can trip up even the most seasoned regulatory professional submitting a safe and effective device for review. In this webinar, we briefly explore common findings from notified bodies and the U.S. Food and Drug Administration (FDA) and how you can avoid them!

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