Quick Tip: Create design inputs from system level user needs and safety requirements

Insight from a conversation with Chuck Ventura

May 27, 2024

LTR 43: Tips for integrating risk analysis with design controls

Mar 8

One of the key requirements of ISO 13485, the International Standard for medical device Quality Management Systems is establish a link between risk management and the design and development process. In practice this proves to be quite challenging. In this Let’s Talk Risk! conversation, Chuck Ventura shares that medical device design and development proce…

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Quick Tip: Create design inputs from system level user needs and safety requirements

Insight from a conversation with Chuck Ventura

Listen to the full podcast here

LTR 43: Tips for integrating risk analysis with design controls

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