Design Transfer

The design control regulation requires that "Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications."

Design transfer comprises the activities needed to move a product from the development engineering environment into the manufacturing environment. This commonly involves process development, documentation of the process, and validation. Of these, process validation is area in which regulatory problems most often arise. Industry and regulatory understanding of what constitutes validation is still evolving.

AlvaMed can help you navigate the process validation issues facing the medical device manufacturing community. We can help you determine which processes require validation and how to best perform the validation, including the use of DOE, IQ, OQ, and PQ. We can also assist you in performing a process risk analysis to to plan an efficient and effective test and inspection program.

We also assist larger companies that have acquired smaller start-up companies which have a product ready to transfer to manufacturing. Oftentimes issues between the quality systems and other requirements of the acquiring company are significantly different than those of the acquired company. This discrepancy can lead to many roadblocks in the design transfer process. Many of AlvaMed's consultants have extensive design, design transfer, and manufacturing experience in both small and large companies and can help resolve the issues that arise and negotiate issues before they delay the transfer.

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