Exploring Standards with Assent
Understanding ISO 13485 for Medical Devices with Sarah Smith
Sarah Smith joins host Jess on Exploring Standards to discuss ISO 13485 for medical devices. The episode covers the standard's importance, key QMS components, risk management, and its relation to GMP and regulatory compliance in the UK and Europe.
Mentioned
topics
- iso 13485
- medical device quality management systems
- risk management in medical devices
- good manufacturing practice
- regulatory compliance in uk and europe