Design Controls (DHF/DMR)
Build a robust Design History File (DHF) that demonstrates safety and efficacy.
What We Do
Design controls are the proof that you designed your device correctly. We help you structure your design and development process to meet 21 CFR Part 820.30 and ISO 13485 requirements.
- Design History File (DHF): Compilation of all design records, from inputs to validation.
- Traceability Matrix: Linking user needs, design inputs, outputs, and verification/validation.
- Device Master Record (DMR): The recipe for manufacturing your device.
- Design Reviews: Facilitation and documentation of critical design reviews.
Deliverables
Complete DHF Index
Traceability Matrix
DMR Structure
Design Review Minutes