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Event Type

June 2022


02 June

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

Presented By:

RQM+ Live! #56 — Clinical Evidence vs. Clinical Performance – A Deep Dive into MDCG 2022-2 and Notified Body Expectations


Virtual Event

Speakers:
Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
Heike Möhlig-Zuttermeister​, Ph.D. – Vice President of IVD Intelligence & Innovation
Bethany Chung, Ph.D., RAC – Principal Regulatory Scientist
Ron Sills – Senior Principal Specialist

What are the differences between evidence and performance? What are notified body expectations? We invite you to join us!

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05 June - 07 June

Presented By:

True Quality 2022


San Diego, CA

Speakers:
Allison Komiyama, Ph.D., RAC, President, AcKRS and Principal Consultant, RQM+

Into the Unknown: A look at where your file goes when you send it off to FDA

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20 June - 24 June

Presented By:

MedTech Summit Europe 2022


Dublin, Ireland

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

Stop by our booth and check out our speaking session.

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22 June

5:15 PM - 6:15 PM ET | 11:15 PM - 12:15 AM CET

Presented By:

DIA 2022 Global Annual Meeting


Chicago, IL

Speakers:
Nancy Morrison, RAC, RQM+ Executive Director, Regulatory and Quality Consulting Services

How to Manage Device Design Changes Under EU MDR: This session will discuss the most common challenges with managing design changes under EU MDR. Join us to understand how to communicate what constitutes a significant change and create a strategy for design change compliance under MDR.

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22 June

8:00 PM - 8:00 PM ET | 2:00 AM - 2:00 AM CET

Presented By:

Clinical Trials Series: Best Practices on Interacting with FDA


Irvine, CA

Speakers:
Allison Komiyama, Ph.D., RAC, President, AcKRS and Principal Consultant, RQM+

A brief discussion on interacting with the FDA and Pre-subs. The do's and don'ts when interacting with the FDA.

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27 June - 28 June

Presented By:

Survivor: The FDA 510(k) Program Edition


Saint Paul, MN

Speakers:
Allison Komiyama, Ph.D., RAC, President, AcKRS and Principal Consultant, RQM+
Mark DuVal, J.D., President of DuVal & Associates, P.A.
Lisa Pritchard, BSEEE, VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A.

In this two-day, in-person workshop, regulatory experts will review the current requirements and expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program, providing you with the tools to be a survivor of this ever-changing program.

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September 2022


11 September - 13 September

Presented By:

RAPS U.S. Convergence 2022


Phoenix, AZ

More details coming soon!

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