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.In this webinar, ETQ Chief Technology Officer Morgan Palmer and Ujjal Chakravartty, Director of Global Quality Systems at Avanos Medical Inc. will cover:
Ujjal Chakravartty, 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.