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Quality manufacturing of a medical
device requires not only an effective process for translating the
design into manufacturing specifications but also the verification
and validation of processes and a consideration of the risks liable
to be introduced by manufacturing. Proquamed has experienced consultants who can assist in the effective design transfer to manufacture and the verification and validation of manufacturing processes. Using a risk based approach to development and manufacturing Proquamed will help ensure that the processes comply with the requirements of national and international regulations and cGMP. |
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