P
I have to create a quality system for a small medical device company that performs design and development functions- gains permission to market the devices (FDA clearance, CE Mark, etc.); and then subcontracts manufacturing of the devices to other companies. It is not, and will not be, actively engaged in manufacturing of product for human (other than possible clinical trial) use,but it does release the product to its distributors that is produced by the contract manufacturer.
I have attempted to address its "production" functions under its product realization activities by calling them "design transfer", which allows it to teach the methods and transfer specifications it developed, verified, and validated during the design phase. However, this does not cover the product release activities it performs.
Because it releases the product, do all of the production-related requirements of Section 7.5 need to be addressed in the quality system, or do I only need to address product release? I have attempted to only address product release. Has anyone had experience with this, or similar situations? If so, did they obtain buy off from their NB? the FDA?
Any thoughts, and especially reports of any experience with this situation, would be appreciated.
Thanks!
Phil
I have attempted to address its "production" functions under its product realization activities by calling them "design transfer", which allows it to teach the methods and transfer specifications it developed, verified, and validated during the design phase. However, this does not cover the product release activities it performs.
Because it releases the product, do all of the production-related requirements of Section 7.5 need to be addressed in the quality system, or do I only need to address product release? I have attempted to only address product release. Has anyone had experience with this, or similar situations? If so, did they obtain buy off from their NB? the FDA?
Any thoughts, and especially reports of any experience with this situation, would be appreciated.
Thanks!
Phil
