Design and Development Planning

The design control regulation requires that "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."

All product design and much of the subsequent ECO activity tat occurs after a product is placed on the market requires such planning documents to be in place. AlvaMed can provide a methodology to make the generation of these planning documents almost routine and much less time consuming than starting from a blank sheet of paper each time. The resultant plans, however, will cover all the major planning aspects necessary to demonstrate control of the design projects and be in compliance with the regulations.

Let us show you how you can simplify your planning obligations.

We invite you to review some case studies that are representative of the work done by our consultants...

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