ODM not 13485-certified

#1
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?
 
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somashekar

Staff member
Super Moderator
#2
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?
This is a classic case of Risk assessment applied to Controls over outsourced process.
Do not look at Audit ONLY as your control. Let your risk assessment applied judiciously towards your specific out sourced process bring about all the controls that you would want to exercise, and make sure how your second party audit of the company will be able to evaluate all your controls effectively. Your risk assessment output will feed in as your audit checklist. Make sure you establish written quality agreements with the company.
Hope this helps you...
 

yodon

Staff member
Super Moderator
#3
Are there any other concerns or consideration that I should be aware of?
IEC 62304 is harmonized in the EU and recognized in the US. You'll probably want to ensure they are compliant to that. You'll probably want to do a gap analysis to determine how to cover any gaps and as @somashekar notes, execute a quality agreement to ensure things are well understood.

It's been my experience that your auditor will likely want to audit them.
 
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