Medical Devices 2021 - Understanding the Design Verification and Validation Requirements for Medical Devices Webinar

Design Verification and Validation (DVV) for Medical Devices is getting a lot of attention today as it is very challenging to understand and fulfil the DVV needs for Class I to Class III devices. In the current environment of global standardization of quality and regulatory needs, learning to understand and interpret the risk based FDA’s DVV regulatory requirements for medical device
Learn how to interpret FDA and ISO 13485:2016 DVV requirements for your product to fulfill global and medical device requirements and specifically in the FDA quality and regulatory arena where the phase I to Phase IV DVV meetings and their documentation is the key for your product evolution.
Will review FDA DVV definitions and expectations based on her personal experience in executing DVV in device companies
Will incorporate several examples based on the FDA Requirements so you can integrate them into your product risk management for commercialization
Speaker:
Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States.