Medical device companies are acutely familiar with FDA regulations and likely certified to, or working toward, a quality management standard like ISO 13485. Those that seek to expand business need to invest in two more pathways to success: the Medical Device Single Audit Program (MDSAP) and European Union Medical Device Regulation (EUMDR).
What are they and why should any medical device manufacturer care? This free, one-hour info session provides answers to both. We will introduce MDSAP, an optional compliance program that is altering the availability of markets for those that don’t jump aboard. Participants will also hear about EUMDR, the regulation taking effect in 2021 essential to selling products in Europe.
Join us for a peek at what companies need to do to conform.
Regulatory and quality personnel, as well as senior executives, of medical device manufacturers
10 a.m.
April 29, 2020
Online webinar
Mr. Riggi has over 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.
Another session may be scheduled if there is enough demand. Contact Gary Simon at ggsimon@buffalo.edu if interested.