We have a supplier of a high-level assembly which we include in our final medical device product. Are we as manufacturers responsible to set validation requirements of our suppliers, or are medical device suppliers required to validate based on any standard or regulation? Thanks in advance.
Steve-
[quote=mattossa]We have a supplier of a high-level assembly which we include in our final medical device product. Are we as manufacturers responsible to set validation requirements of our suppliers, or are medical device suppliers required to validate based on any standard or regulation? Thanks in advance.
Steve-[/quote]
You, as the manufacturer of record, are responsible to ensure the regulations are met. So, for example, if you outsource a manufacturing process whose results are not 100% verified, there is an expectation that the process be validated. How you arrange that with your supplier is up to you but the results must be available and meet the regulations.
Yodon is exactly right. Regardless of who makes your product, part of it or performs a service on it, you own the license for that product and have the responsibility for it.
In addition, you perform the assessment/audit of the vendor because their process for controls, validation, testing need to meet your needs as well. A vendor who performs an inadequate validation or testing has the potential to impact their product (or their CofC or CofA). Not being aware of their deficiencies does not remove your responsibility. Hence, risk based has become much more prevalent as we determine from audits what risk we inherit from a vendor and what actions are required to control or remediate that risk.