FDA’s New Medical Device QMSR: Everything You Need to Know From an FDA & Global Expert!
Program Speaker:
Kim Trautman, M.S.
Medical Device, IVD, and
Combination Product Expert
Event Agenda:
DATE: Thursday, 22 August 2024
TIME:
PDT – Pacific Daylight Time
11:00 AM – 11:05 AM Welcome and Announcements
11:05 AM – 12:05 PM Program Presentation
12:05 – 1:00 PM Q & A
LOCATION: This event is being offered virtually. The zoom link will be shared with you via email 1-2 days before the event.
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Click here to register for this event.
Program Topic:
FDA officially, published in the Federal Register on February 2, 2024, the new Quality Management
System Regulation (QMSR) which is the first revision of 21 CFR 820 since 1996. FDA has incorporated
ISO 13485:2026 into the regulation by reference and has additional U.S. country specific requirements.
In addition, the Federal Register contained the concurrent amendment to Combination Product GMP
requirements in 21 CFR Part 4. Hear first-hand from the 1996 QS regulation author and ISO 13485
International TC 210 QMS expert on how these changes will affect medical device manufacturers from
the requirements to the comments in the Preamble, to FDA medical device inspections, and more…
-Understand the “Nuts and Bolts” of this new FDA revisions to 21 CFR Part 820 and 21 CFR Part 4
-Learn the specifics of the U.S. country specific requirements “By The Numbers”
-Plan for the “Increase in Regulators Expectations”
-Be aware of the “Possible Surprises – Combination Products”
While many medical device manufacturers who are already certified to ISO 13485:2026 may think this
new regulation is not a "big deal" – there are nuances and influences from the FDA QMSR that every
manufacturer must be aware of. This presentation will not only cover the needed basics but dive
deeper into those nuances and tangential influences.
Speaker Biography:
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination
Product Expert with over 40 years of experience. She worked at the US Food and Drug Administration
(FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry
experience as well as regulatory agency experience. Demonstrated history of working collaboratively
with industry, regulators and patient groups for the betterment of public health. Executes several
medical device regulatory services and developed a formal Education/Training business. Established
an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified
Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System
Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and
developed the Medical Device Single Audit Program and its consortium of five Global Regulators.
Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the
International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device
expert with a Master's Degree in Biomedical Engineering.
Registration Information:
- Register for the event here
Contact
Pricing – Online – Registration (ends Wednesday, August 21st, 2024)
| Registrant Type | Event Price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member |
$20.00
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Cancellation Policy
There will be no refunds for cancellations.
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