6 FDA QMSR + ISO 13485 design control templates. Build a compliant design history file without starting from scratch.
Instant download. For QA/RA teams at Class II and III device companies.
FDA QMSR 21 CFR 820.30 requires documented design controls for Class II and III devices — covering requirements capture, formal reviews, V&V, and the full design history file. ISO 13485 §7.3 layers on top for international market access.
Most teams start from scratch or patch together documents from different sources. This toolkit gives you six purpose-built templates — from the design control plan through design transfer — structured the way FDA investigators and notified bodies expect to see them.
Structured in the order you would build the design history file.
FDA QMSR 21 CFR 820.30 + ISO 13485 §7.3 compliant plan. Covers design stages, review gate criteria, inputs/outputs mapping, and responsible parties. Pre-structured for Class II and III device programs.
Capture functional, performance, safety, and regulatory requirements in a structured format. Includes traceability setup linking inputs to outputs, verification, and validation. Built for design control completeness.
V&V plan structure with individual test protocol templates. Includes acceptance criteria framework, test method documentation, and evidence linking back to design inputs. Covers both bench verification and clinical/use validation.
Complete DHF structure per FDA expectations. 40+ checklist items covering every required section. Audit-ready format — use as a gap assessment before inspection or as the scaffolding for a new design project.
Structured design review agenda with pre-meeting inputs, attendance tracking, open issue log, and gate approval criteria. Maps to QMSR and ISO 13485 formal review requirements. Captures reviewer sign-off.
Design freeze to manufacturing transfer procedure. Includes production equivalence testing checklist, device master record (DMR) handoff, and change control triggers. Ensures manufacturing can reproduce the design.
Every template maps directly to 21 CFR 820.30 requirements. Built for the QMSR era — not legacy QSR.
Dual-jurisdiction coverage. Same templates satisfy ISO 13485 §7.3 design and development requirements.
The DHF checklist scaffolds your entire design history file. Know exactly what goes where before the auditor arrives.
Verification and validation protocol with test templates. Link every test back to your design inputs.
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“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
Design controls are the documented processes that govern how a medical device is designed — from initial requirements through verification, validation, and transfer to manufacturing. FDA QMSR 21 CFR 820.30 requires them for Class II and III devices. Without a complete design control system, FDA investigators and notified bodies will issue observations. More importantly, poor design controls are directly linked to recalls.
The Design History File (DHF) is the record of the design process — it documents how the device was designed. The Device Master Record (DMR) is the blueprint for manufacturing — it documents how the device is made. The DHF lives in R&D; the DMR lives in manufacturing. Design transfer is the formal handoff between the two. Document 04 (DHF checklist) and Document 06 (Design Transfer SOP) cover this boundary explicitly.
Both are required under 820.30(f) and (g). Verification answers "did we build the design right?" — it confirms the design output meets the design input. Validation answers "did we build the right design?" — it confirms the device meets user needs and intended uses in actual or simulated use conditions. Most Class II devices require both bench verification and usability/performance validation.
Design transfer (820.30(h)) is where most manufacturers cut corners. The core requirement: manufacturing processes must be verified as capable of producing a device that meets the design specifications. This means production equivalence testing, a complete DMR handoff, and a formal change control process for any deviations found during transfer. Document 06 provides the SOP and checklist.
Yes. All six templates include ISO 13485 §7.3 annotations alongside QMSR references. The design control plan and DHF checklist explicitly call out ISO 13485 section mappings so you can demonstrate compliance to a notified body using the same documents you use for FDA.
No. This is a practitioner reference toolkit built by people with hands-on FDA and ISO 13485 audit experience. For formal regulatory counsel, consult a licensed regulatory affairs professional.
Start with the right structure. Add your device-specific data. Satisfy both FDA and ISO 13485.
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