OnDemand Webinar with FDAnews:
How to Prepare for FDA Migration from QSR to ISO 13485 and QSIT to MDSAP

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:

  • Key elements of ISO 13485:2016 and MDSAP
  • The payoff for making the MDSAP transition
  • Issues that may crop up along your transition to MDSAP

Speakers:

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.

Morgan Palmer, Chief Technical 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.
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FDA Migration Webinar Replay