Design Controls
A Design History File that traces every requirement to an output, verification, and validation.
Run device design and development as a controlled Design History File: capture design inputs (user needs, functional, performance, safety, regulatory, interface) and design outputs, link every input to the outputs that satisfy it, and record verification (outputs meet inputs) and validation (the device meets user needs). A live traceability matrix shows exactly which requirements are covered — and which are not.
The lifecycle (Planning → In Development → Verification → Validation → Design Transfer → Closed) is enforced server-side with e-signature gates at each stage. Verification can't be signed while any input is untraced or any verification is pending; validation can't be signed while any validation is pending; and the person who signs validation can't be the one who signed verification. A design review is e-signed and cannot be recorded until it names its participants and the function each represented (ISO 13485 §7.3.5); a review with a single participant is accepted only with a recorded reason. Every action is bound to the record's content hash and written to the immutable, hash-chained audit trail.
- ✓ Live requirement-to-output traceability matrix with gap flags
- ✓ Verification and validation records tied to specific inputs and outputs
- ✓ Stage-gate e-signatures with segregation of duties (verifier ≠ validator)
- ✓ E-signed design reviews that record every participant and the function they represented
- ✓ Sign-off blocked until traceability and pending results are resolved