Quality Management Systems Expert Witnesses

In Medical Device Design Controls – Transfer, Changes, and History, quality management systems expert witness Philip J. O’Keefe, PE, MLE, discusses design transfer procedures:

Meant to ensure that medical device designs are correctly translated into production specifications for manufacturing, Design Transfer Procedures keep those directly involved with the manufacturing process in check. It is absolutely vital that those involved in manufacturing receive accurate and complete information…

A Design Transfer Procedure would ensure that a variety of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management. For example, a Design Transfer Procedure would lay out responsibilities of supervisors and managers to make sure the latest revision of electrical schematics, bills of materials, Gerber files, and quality testing procedures are received by the manufacturer of a device’s printed circuit boards. It’s important that the order is received in a timely manner so as not to hold up the manufacturing process. However, it’s much more important that the printed circuit board is made properly, the correct electrical components are placed on it in the correct orientation, and it is tested to make sure it doesn’t malfunction after assembly.

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