The DHF is what FDA asks for during a 510(k) review. The DMR is what your manufacturing team needs to build the device. Affinity QMS DHF/DMR Management structures both — with phase-gated design controls, V&V record linking, and a 510(k) submission package generator that eliminates weeks of document compilation before your FDA submission.
DHF Phase Gate Structure
Each phase gate requires documented completion before the next phase begins — satisfying 21 CFR Part 820.30 design control requirements and ISO 13485 Clause 7.3.
Design History File (DHF) Structure with Phase Gates
The DHF is pre-structured with phase gates matching 21 CFR Part 820.30 design control requirements — Design Planning, Design Input, Design Output, Design Review, V&V, Design Transfer, and Design Changes. Each phase gate requires documented completion and approval before the project advances, ensuring design controls are followed — not just documented retroactively.
Design Input and Output Management
Capture design inputs — intended use, user needs, performance specifications, regulatory requirements — and link each output to the input it satisfies. The traceability matrix between design inputs and outputs is automatically maintained and exportable for FDA submission. Design input changes trigger an impact assessment on all linked outputs.
Design Verification and Validation (V&V) Record Linking
Link each verification and validation protocol directly to the design input or output it tests. V&V records — including test protocols, data, acceptance criteria, and approval signatures — are stored within the DHF and linked to the Validation Protocol Engine for IQ/OQ/PQ execution. The result: a complete V&V summary with one-click traceability.
Design Review Meeting Records
Schedule and document formal design reviews at each phase gate. Design review records capture attendees, agenda, design artifacts reviewed, issues identified, action items, and formal approval decisions. Electronic signatures from all required reviewers are captured — satisfying ISO 13485 Clause 7.3.5 and 21 CFR Part 820.30(e).
Design Transfer to Production (DMR Linkage)
The design transfer phase formally moves approved design outputs into the Device Master Record. DMR documents — manufacturing specifications, component drawings, assembly procedures, quality requirements, and labeling specifications — are linked to the DHF outputs they implement. The DHF-to-DMR traceability is maintained automatically and accessible for FDA inspection.
DHF→510(k) Submission Package Support
When your 510(k) preparation begins, Affinity QMS generates a pre-organized submission package from your DHF — design summary, substantial equivalence documentation, V&V summary, labeling, and performance testing data. The package output follows FDA's 510(k) eSTAR format guidance — reducing submission preparation from weeks to days.
Risk Management Integration (ISO 14971 FMEAs)
Link risk management records from the Risk Management module directly to DHF design inputs and V&V records. FMEAs, risk controls, and residual risk acceptability determinations are cross-referenced within the DHF — providing the risk management file integration required by ISO 13485 Clause 7.1 and the FDA QMSR.
DHF/DMR + Validation Protocol Engine: The Complete Device Development Package
Every DHF in Affinity QMS is integrated with the built-in Validation Protocol Engine. V&V protocols are auto-generated based on your device type and manufacturing process — IQ, OQ, and PQ protocols ready for execution and FDA review. No external consultant. No canned validation package. Your auditor asks for VPs — you hand them over.
Explore Validation Protocol Engine| Regulation / Standard | Clause / Section | DHF/DMR Coverage |
|---|---|---|
| 21 CFR Part 820.30 | Design Controls | Full design control process: planning, input, output, review, V&V, transfer, changes, DHF |
| 21 CFR Part 820.181 | Device Master Record | DMR contents, location, maintenance, accessibility |
| ISO 13485:2016 | Clause 7.3 — Design and Development | Planning, inputs, outputs, review, verification, validation, transfer, control of changes |
| FDA QMSR (2024) | Design Controls (incorporates ISO 13485 Clause 7.3) | Full design control lifecycle aligned to QMSR and ISO 13485 |
| ISO 14971:2019 | Risk Management Throughout Lifecycle | Risk management file integration, design input linkage, V&V risk control linkage |
Further Reading
New to DHF requirements? Read our plain-language guide: What is a Design History File and Why Your Startup Needs One Now — written for first-time device developers navigating 21 CFR Part 820.30 for the first time.
Included in Compliance Suite — Starting at
$1,799/mo
DHF/DMR Management is included in the Compliance Suite ($1,799/mo) and Full Platform ($3,499/mo). It includes full integration with the Validation Protocol Engine — no separate purchase required.
Book a demo and see how Affinity QMS structures your Design History File and Device Master Record — from first design input through 510(k) submission package generation.