SaaS SaMD - Impact QMS

#1
Hi,

I am planning to develop SaaS SaMD. My organization is certified for ISO 13485: 2016. Interested to understand the impact of QMS for the same. Which all clauses of ISO 13485 will be affected.
Appreciate your valuable thoughts.

T&R,
 
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#2
Software is just another product so everything is applicable, maybe with more direct application for product realization. Things like contamination control are obviously not applicable. The "manufacturing" process is a bit weird, especially for a SaaS product.

13485 is the quality system under which you operate. You probably want to look at IEC 62304 for more specifics relevant to the software lifecycle for medical devices (including SaMD). Another relevant standard is IEC 62366 for usability engineering. There may be others depending on the nature of your software. Compliance with those will smooth the regulatory clearance process.
 
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