Design Controls
Design controls are a critical chapter of KGMP (aligned with ISO 13485:2016 Section 7.3) and are particularly scrutinised during MFDS inspections for higher-risk devices (Grade III and IV). Deficiencies in design control documentation are among the most common inspection findings.
Key requirements
- Design and development planning — plan describing stages, responsibilities, and timelines
- Design inputs — functional, performance, safety, and regulatory requirements documented
- Design outputs — documented and verified against inputs before release
- Design review — formal reviews at defined stages with documented results
- Design verification — confirming design outputs meet inputs
- Design validation — confirming the finished device meets user needs and intended use
- Design transfer — ensuring design can be manufactured consistently
- Design changes — controlled and evaluated for impact before implementation
MFDS inspection focus
Inspectors will look for:
- Traceability from design inputs through to outputs, verification, and validation
- Evidence that verification and validation were conducted on representative final devices
- Change control records for any design modifications