Hi all,
I recently joined a medical device start-up for putting in place a QMS. We are in Design and Development Phase and using a contract manufacturer. Until now we were relying on the CM's quality system and documentation, however I now want to put in place Design Controls procedures from our side as well. My question is how exactly should I properly document it and implement it, since the effective date of our procedures will be much later after the design and development process actually started? What would be the best way to integrate documents from our CM (different numbering and everything) into our Document System?
I recently joined a medical device start-up for putting in place a QMS. We are in Design and Development Phase and using a contract manufacturer. Until now we were relying on the CM's quality system and documentation, however I now want to put in place Design Controls procedures from our side as well. My question is how exactly should I properly document it and implement it, since the effective date of our procedures will be much later after the design and development process actually started? What would be the best way to integrate documents from our CM (different numbering and everything) into our Document System?