The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard.
In February 2026, the FDA will move away from the Quality System Regulation (QSR) and adopt the ISO-13485-based Quality Management System Regulation (QMSR).
Though a seemingly simple transition, there are actions that each medical device manufacturer must adopt in order to comply.
This four-hour course is designed for Medical Device Quality Assurance, Regulatory Affairs, Manufacturing Quality and Design Quality personnel and will focus on the process required to successfully transition from QSR to QMSR.
Hours: 4
Recommended for individuals with knowledge in 21CFR820 and ISO-13485(2016)
None
8 a.m. to 12 p.m.
February 4th, 2026
Baird Research Park, Room 206/208
1576 Sweet Home Road
Amherst, NY 14228
Mr. Riggi has 40 years of experience in quality assurance and regulatory affairs management at major companies, including Bausch & Lomb, Novartis and Baxter Healthcare. In each role, he has been responsible for global quality system design, manufacturing quality and regulatory compliance. He began his career with implementation of quality systems, as per requirements of the initial 21CFR820 regulation. He has overseen medical device compliance to 21CFR820, ISO-9001 and ISO-13485, as well as product regulatory compliance.
$275
Any questions, please contact:
Gary Simon
ggsimon@buffalo.edu
(716) 645-8837
To register, please fill out this form. You will then be taken to the payment page. Payment is due at least two weeks before you start the course.