Medical Device: ISO 13485 Training Requirements

In regulated environments, training is necessary to make the concept of quality a reality. It’s the reason why quality regulations and standards require a formal training control and management process. ISO 13485 training requirements are meant to help medical device manufacturers and suppliers achieve that goal. The standard was updated in 2016 to address technological advances and adapt to a changing regulatory landscape.

Compliance with 21 CFR 820 and ISO 13485 Using MasterControl