We are small company launching our first medical device product. There is some debate as to the role of the Quality Assurance department during the Design and Development phase. There are two camps:
Camp A: QA assures compliance to QMS, ISO and the CFR in addition to ensuring that testing protocols are strong and reports provide strong evidence while being involved in the decision making that may affect the quality of the product.
Camp B: QA assures compliance to QMS, ISO and the CFR by make sure that the correct documents are completed and signed by the appropriate approvers - more of document and data control role.
In a strong D&D process, should Quality have a more active role (examples: assuring the appropriate testing is done, evaluating the validity of the test results, as well as be involved in decisions about testing sample size and statistical techniques used during analysis)?
Camp A: QA assures compliance to QMS, ISO and the CFR in addition to ensuring that testing protocols are strong and reports provide strong evidence while being involved in the decision making that may affect the quality of the product.
Camp B: QA assures compliance to QMS, ISO and the CFR by make sure that the correct documents are completed and signed by the appropriate approvers - more of document and data control role.
In a strong D&D process, should Quality have a more active role (examples: assuring the appropriate testing is done, evaluating the validity of the test results, as well as be involved in decisions about testing sample size and statistical techniques used during analysis)?