FDA Support Services
Knowvention Supports Design Reviews as Independent Experts
We work to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.
We are experienced with multiple Device Classes I, II, and III, 510k or PMA and can support you with the following areas as an independent advisor:
- Design Controls
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer