ASQ Temecula Valley Section 0713 & SC LNG RAPS
announce our next meeting 6:00pm PST Wed 1/21/26
"FDA’s New Medical Device QMSR: What You Need To Know. It is not as simple as relying upon past ISO 13485:2016 certification efforts"
Kim Trautman, M.S., Medical Device, IVD and Combination Product Expert
Talk Description:
FDA’s Quality Management System Regulation (QMSR) comes into full effect February 2026! This is FDA’s first revision of 21 CFR 820 since 1996. FDA has incorporated ISO 13485:2016 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, MDSAP, and more…
“Nuts and Bolts” of this new FDA revisions to 21 CFR Part 820 and 21 CFR Part 4 “By The Numbers” will discuss specifics of the U.S. country specific requirements “Increase in FDA’s Expectations” will assist in understanding the regulations preamble and legal intent “Possible Surprises” - Combination Products with device delivery systems need pay particular attention to new requirements.
Understand the upcoming new FDA QMS requirements which are in addition to ISO 13485:2016. Learn some of the nuances and increase emphasis from the regulation’s preamble. Discuss the value of Gap Analysis and transition planning along with other regulatory obligations before February 2026.
Those who will benefit from this presentation most directly include:
Regulatory Affairs Managers, Quality Managers and Quality Engineers,
Research and Development Engineers/Scientists and Project managers.
Speaker Biography
Kimberly A. Trautman is an experienced and recognized International Medical Devices, IVD, and Combination Product Expert with over 40 years of experience. She worked at the US Food and Drug Administration (FDA) for over 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.
Expert in global medical device regulations, wrote and harmonized the 1996 US FDA Quality System Regulation. Was on the international authoring group of ISO 13485 since inception and continues to date. Part of the FDA authoring group for 21 CFR Part 4 Combination Product GMPs and many of the Combination Product guidance documents. Conceived and developed the Medical Device Single Audit Program (MDSAP) and its consortium of five Global Regulators which she chaired for the initial four-years of the program. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Executes several strategic, quality and regulatory services. Established an Authorized MDSAP Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
"FDA’s New Medical Device QMSR: What You Need To Know. It is not as simple as relying upon past ISO 13485:2016 certification efforts" Webinar by Kim Trautman, sponsored by Temecula Valley Section 0713 ASQ and Southern California Local Networking Group Regulatory Affairs Professionals Society at 6:00 pm – 8:30 pm PST, January 21, 2026
Webinar topic:
"FDA’s New Medical Device QMSR: What You Need to Know!"
Date and time:
Wednesday, January 21, 2026 6:00 PM | (UTC-07:00) Pacific Time (US & Canada)
Join link:
https://asq.webex.com/asq/j.php?MTID=m22160a4f38a34cb147359d8bee9406f3
Webinar number:
2557 041 8152
Webinar password:
3dfMuFskQ83 (33368375 when dialing from a phone or video system)
Join by phone
1-877-668-4490 Call-in toll-free number (US/Canada)
1-408-792-6300 Call-in toll number (US/Canada)
Access code: 255 704 18152
Thank you,
Brent Perguson
2025 Section Chair