Hi
We are looking to outsource the design and manufacturing of a SaMD to a company that does not hold a 13485 certificate. We evaluated that the company had the competencies needed for making the particular software, but it was not feasible to ask them to become certified for 13485 just for our product.
I imagine that during the supplier audits, we will have to audit the ODM thoroughly as a NB would audit us if we were to own the design and manufacturing processes ourselves. Are there any other concerns or consideration that I should be aware of?
We are looking to outsource the design and manufacturing of a SaMD to a company that does not hold a 13485 certificate. We evaluated that the company had the competencies needed for making the particular software, but it was not feasible to ask them to become certified for 13485 just for our product.
I imagine that during the supplier audits, we will have to audit the ODM thoroughly as a NB would audit us if we were to own the design and manufacturing processes ourselves. Are there any other concerns or consideration that I should be aware of?