Hi all, when you contract a "Test Laboratory" supplier to write test protocols and perform controlled testing to meet standard(s), do you perform audits of them (either in-person or remotely) as part of your supplier evaluation/qualification procedure?
Do you also sign a formal Supplier Quality/Regulatory Agreement with them? Or do you instead just get a Quote document from the Test Laboratory, then you provide a Purchase Order, which acts as the contract for performing testing services to meet the standard(s).
I myself am part of a medical device startup and we're getting quotes from various test laboratories to perform our "design verification" testing on our medical device prototype for things like biocompatibility validation, cleaning validation, sterilization validation, etc. We feel that at a minimum, a remote audit is required, to confirm that they have calibrated equipment, training, etc. But we feel that you wouldn't normally sign a Supplier Quality/Regulatory Agreement for performing lab testing like this.
Do you also sign a formal Supplier Quality/Regulatory Agreement with them? Or do you instead just get a Quote document from the Test Laboratory, then you provide a Purchase Order, which acts as the contract for performing testing services to meet the standard(s).
I myself am part of a medical device startup and we're getting quotes from various test laboratories to perform our "design verification" testing on our medical device prototype for things like biocompatibility validation, cleaning validation, sterilization validation, etc. We feel that at a minimum, a remote audit is required, to confirm that they have calibrated equipment, training, etc. But we feel that you wouldn't normally sign a Supplier Quality/Regulatory Agreement for performing lab testing like this.