ISO 13485 Medical Device QMS Templates

Editable ISO 13485 and ISO 14971 templates for medical device manufacturers, distributors and design-only companies: document control, design controls and DHF, CAPA and complaints, supplier control, internal audit, risk management, training kits and complete QMS-in-a-Box systems. Instant download in Word and Excel, licensed for one organization.

The ISO 13485 collection is organised two ways: by the part of the standard each kit covers, and by the type of medical device company you are.

How do ISO 13485, FDA QMSR and EU MDR line up?

FDA's Quality Management System Regulation (21 CFR Part 820) took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference, so one ISO 13485 system can serve both. In the EU, manufacturers must meet Article 10(9) of Regulation (EU) 2017/745, and EN ISO 13485:2016/A11:2021 appears in the Commission's list of harmonised standards for that regulation. The table shows where common topics sit. The EU column is our subject-matter reading of Article 10(9); the official clause-to-article correspondence is in the annexes of EN ISO 13485:2016/A11:2021. A dash means we have not verified an entry.

Topic ISO 13485:2016 FDA QMSR (21 CFR 820) EU MDR 2017/745
Quality management system 4.1, 4.2 820.10(a): document a QMS that complies with applicable ISO 13485 requirements Article 10(9): QMS must address at least items (a) to (m)
Risk management 7.1 Through ISO 13485 (820.10(a)) Article 10(9)(e)
Design and development 7.3 820.10(c): Class II, Class III, listed Class I and software-automated devices Article 10(9)(g), product realisation
Design file (formerly DHF) 7.3.10 DHF term eliminated; content expected under 7.3.10 Article 10(9)(g)
Medical device file (formerly DMR) 4.2.3 DMR term eliminated; content sits in the medical device file –
Unique device identification and traceability 7.5.8, 7.5.9 820.10(b)(1) and (b)(2); 820.10(d) for implantable and life-sustaining devices; 820.35(c) Article 10(9)(h), UDI
Labelling and packaging 7.5.1, 4.2.5 820.45 –
Servicing records 7.5.4 820.35(b) –
Complaint handling 8.2.2 820.35(a) complaint records Article 10(9)(i), post-market surveillance
Reporting to authorities, advisory notices 8.2.3, 7.2.3, 8.3.3 820.10(b)(3) (Part 803) and (b)(4) (Part 806) Article 10(9)(k), serious incidents and field safety corrective actions
Corrective and preventive action 8.5.2, 8.5.3 Former 820.100 removed; ISO 13485 clauses apply Article 10(9)(l)

Read next: FDA QMSR explained, QMSR and ISO 13485 alignment and the CAPA, design controls, quality manual, internal audit and gap assessment pages.

Sources: eCFR, 21 CFR Part 820; FDA, QMSR; Federal Register, 2 February 2024 (clauses 4.2.3, 7.1, 7.3.10, 8.5.2, 8.5.3); Regulation (EU) 2017/745, Article 10(9); Implementing Decision (EU) 2021/1182, as amended; BSI on the A11:2021 annexes. This is general information, not legal advice. Check requirements against your own licensed copy of ISO 13485.

Three ways to buy ISO 13485 templates

Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.

Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment WorkbookStarter Kit Core system: 6 kits for clauses 4 to 6 and 8 $249 $504View Starter KitBest valueComplete QMS Kit All 15 kits, including design, risk and production $449 $1,375View Complete QMS Kit
Gap assessment, 71 requirement areas with action plan
Quality manual and management review kit
Document control and records kit
CAPA and nonconformance kit
Internal audit kit
Training and competence kit (8 modules)
Design controls and DHF kit, ISO 14971 risk management file kit
Supplier control, production and traceability, equipment and calibration kits
Software validation, medical device file and labelling kits
Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack
Start-here roadmap to certification
Optional 60-minute onboarding call with the author
30-day money-back guarantee, instant download, one-organization licence, free updates for this edition

Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?

Instant downloadFiles by email within minutes
Fully editableWord, Excel, PowerPoint. No macros
30-day money-back guaranteeDoesn't fit your system? Full refund, no fuss
Free updatesRevised files sent free when the standard changes

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