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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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 21, 2020