Question about SaaMD
Is your toolkit for MDR compliance optimized for software as a medical device?
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Our ISO 13485:2016 & MDR documentation toolkit covers the requirements required in the standard itself and general requirements from the MDR. It does not cover the requirements of other standards required for a particular type of medical device. Thus, the Toolkit does not cover the documentation requirements of IEC 62304: 2006 Medical device software - Software life cycle processes.
There are many types of medical products and it is impossible to cover with one toolkit absolutely all the requirements for all types of medical products.
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Apr 26, 2021