Medical Device Commercialization Overview
Transferring the Design to the Manufacturing Function
Will the intent of your design be maintained when it is manufactured?
The final step in developing a medical device for market is to ensure that the product is made in accordance with the way it was designed.
Forma can help you develop all of the documentation that will explain in detail how parts should be made and assembled, the specifications for the materials that should be used, and the conditions that need to be maintained to ensure quality.
The FDA’s Quality System Regulation requires that medical products be manufactured and assembled in accordance with current good manufacturing practice (CGMP). The regulation specifies controls that should be in place so that quality and safety is maintained. Forma can refer you to companies that specialize in developing and implementing full manufacturing quality control systems.