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Guest user Created:   Apr 21, 2021 Last commented:   Apr 26, 2021

Question about SaaMD

Is your toolkit for MDR compliance optimized for software as a medical device?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 26, 2021

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 21, 2021

Apr 26, 2021

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