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We have been asked by our NB to provide evidence that a supplier of a material of animal origin was audited against the requirements of ISO 22442 Medical devices utilizing animal tissues and their derivatives. We have completed the inactivation studies covered in ISO 22442-3, but have not formally audited the supplier against the other elements in the standard. Does anyone have or know where I can find an exisiting checklist that can be used to perform the audit?
Thank you.
Thank you.