ISO 13485 & EU MDR / Documented checklist for SaMD
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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Here you can find the general list of mandatory documents for ISO 13485:2016:
As a manufacturer of software, from that list you do not need the following:
If you do not have any kind of service (repair) in your business, then even the following requirement is not applicable for you:
Furthermore, each medical device software must be in compliance with the following standard:
For more information on ISO 13485, please see the following links:
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