I'm looking for a template to use in developing the context of the organization per clauses 4.1 thru 4.3 of ISO 9001:2015. Has anyone found a...
I'm trying to determine if and regulatory (FDA, ISO etc.) requirements demand that Suppliers or Subcontractors to a Medical Device Manufacturer...
Are suppliers to a Medical Device company required to be ISO 13485 Registered? For example: A supplier is molding a component to a Medical...
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