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IS IEC 62304 included in toolkit Advisera offers?

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Guest user Created:   Oct 19, 2020 Last commented:   Oct 21, 2020

IS IEC 62304 included in toolkit Advisera offers?

Hi there. I have a question regarding your template for ISO 13485 & MDR documentation. We are an artificial intelligence medical software company that have to CE certify our first product. I read that - as a SaMD company - you also need to conform IEC 62304. Is this included in the toolkit Advisera offers?

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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 Oct 21, 2020

Unfortunately, this standard IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes is not included in our toolkit. This standard is very specific and requires certain documentation completely described in the standard.  

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Oct 19, 2020

Oct 21, 2020