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Sk90 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
Design transfer is a complex process involves transfer an approved design into production. Every manufacturer should follow procedure to ensure that design is correctly transfer into production specification. Sometime the product team doesn’t understand or don’t have enough time to create and maintain documents necessary for design transfer. The team should ensure that documentation is complete along with the required verification and validation records .Manufacturers might not get same equipment and procedure as it was planned to use in manufacturing. Design transfer should be a continuous process starting from an early stage where manufacturers observe and learn and lasts to final stage.