hey I am interested in the discussion so I went to the iso webpage. I can't understand why we are getting the accreditation if it isn't needed. I found the following
WHO IS ISO 13485 FOR?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
https://www.iso.org/iso-13485-medical-devices.html
ADO Analysis, page-2238
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