ISO 13485 Design Requirement


Dear Friend ,

Our company manufacturing a medical Device and now we are process ISO 13485 certifications. We need help to prepare Design Document File as per Sec 7.3.

Can anyone have sample file of a Standard Product. Means the product is already available in market since long, which input is not required.

If any one can help me to give us a temple file .

Best Regards,
Tapas Ghosh


Super Moderator
The design and development files encompass everything including planning, requirements, risk management, design documentation, design reviews, verification and validation, etc. There's no single template that would work for everything.


Quite Involved in Discussions
Which markets are you looking at? Each one has different guidelines on the kinds of documentation you are expected to produce - e.g. "Technical Documentation" under EU and UK laws.
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