The FDA is transitioning from the QSR regulation to ISO 13485:2016 for medical devices. In addition, the Medical Device Single Audit Program, MDSAP has gained traction. A single audit system provides many benefits including time and cost savings, less business disruption related to multiple regulatory audits and ease of entry into multiple markets.
Join ETQ Chief Technology Officer Morgan Palmer and Ujjal Chakravartty, Director of Global Quality Systems at Avanos Medical Inc., for a FREE thought leadership webinar sponsored by ETQ.
Key elements of ISO 13485:2016 and MDSAP
The upside: The payoff for making the MDSAP transition
And the downside: Issues that will crop up along the way
Who Will Benefit
Sign Up for FREE Below
Chief Technology Officer, ETQ
Morgan Palmer has been at the forefront of quality management technology for more than 20 years. As the technical architect for ETQ, he drives innovation across the company’s product line to build and enhance quality applications that drive clear business value for ETQ customers. Morgan holds an MBA from the University of Arizona and a bachelor’s degree in marketing, business administration and management from IMIP MBA Institute, Paris.
Director of Global Quality Systems, Avanos Medical Inc.
Ujjal Chakravartty guided Avanos Medical to become one of the first companies to comply with both MDSAP and ISO 13485, thereby realizing significant business benefits. His career includes stints with Kimberly Clark Healthcare, Novartis, Baxter Health Corporation and Johnson & Johnson.