FDA Design And Development Planning (operonstrategist.com)

FDA Design And Development Planning is To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls.

FDA Design And Development Planning:

This stage includes a description for all of the Medical Device Design Control, from the initial project plan and user needs, all the way to product market launch. It includes tasks descriptions, team members, external vendors or collaborators, and their responsibilities. This plan is essential and serves as a roadmap and project management tool, so it is constantly updated to include any plan changes throughout the whole medical device development cycle.

FDA Design And Development Planning Input

Medical FDA Design And Development Planning Input includes the features, requirements and performance criteria of a medical device. This stage is very important as the better the design inputs are, the more effective and efficient the medical device will turn out to be. 

For this reason, medical device developers should define clear, measurable, and objective Design Inputs that aid medical device development down the line. Sources for Design Inputs can be:

• User needs (also known as customer attributes)
• Industry standards and manufacturing capabilities or limitations
• Rules and regulations
• Competitive products features

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