FDA Design Control Guidance for Medical Device Manufacturers
US FDA 21 CFR 820.30 Design Control Requirements.
At the design stage, an outline of the design control process should be actualized. Here is a diagram describing the Design and Development Planning.
There are several parameters which contribute to the design input:
- Business Economics
- Risk Management
- Regulatory Requirements
- Stakeholder feedback (Clinicians, patients, hospitals etc.)
- The fabricated device
- User Manual
- Risk Analysis Study
- Other technical documentation
Design validation follows successful design verification. The design validation takes into account the user needs.