ISO 14971:2019 Medical Device Risk Management System
ISO 14971:2019 Medical Device Risk Management System
An editable risk management system for medical devices and IVDs, built on ISO 14971:2019 and usable for any device class or technology.
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By document type
| Category | Files |
|---|---|
| Policies | 3 |
| Procedures & SOPs | 18 |
| Plans & Programmes | 17 |
| Forms & Records | 133 |
| Checklists & Audit Tools | 102 |
| Registers, Logs & Matrices | 65 |
| Job Descriptions & Organisation | 3 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 7 |
| Tools & Workbooks | 3 |
| Other Documents | 13 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-14971-POL-001 | Medical Device Risk Management Policy | Word |
| AGS-14971-PRO-001 | Risk Management Procedure | Word |
| AGS-14971-PLN-001 | Risk Management Plan Template | Word |
| AGS-14971-PRO-008 | Risk Control Procedure | Word |
| AGS-14971-TMP-003 | Design FMEA Template | Word |
| AGS-14971-REG-027 | Master Risk Register | Excel |
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Overview
A risk management file has to hold together from intended use to post-production. Each hazard leads through a hazardous situation to a harm, each risk is estimated and evaluated against your own criteria, and each control is verified for both implementation and effectiveness. This system keeps that chain intact. Its master risk register calculates risk regions and names the first missing link in each chain.
It follows ISO 14971:2019 practice closely. Hazard, hazardous situation and harm stay separate, no risk matrix is imposed, detectability plays no part in estimation, and FMEA, FTA, HAZOP and similar methods are placed as supporting tools. ISO/TR 24971:2020 is used as guidance, with a matrix that records how each part was applied. The system works inside an ISO 13485:2016 quality management system and links to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Documentation alone does not demonstrate conformity, and no ISO 14971 certification scheme is implied. Regulations are referenced by citation. Standards are referenced by number and title only, and no standard text is included.
What this system covers
- Governance: a risk management policy, master procedure, governance charter, team terms of reference, roles, RACI and competence matrices, a training plan, performance indicators and escalation.
- Planning: a device risk management plan template, intended use and intended purpose statements, user, patient and environment profiles, and development of acceptability criteria.
- Analysis: device characteristic assessments, hazard identification and analysis worksheets, and templates for design, process and use FMEA, FTA, HAZOP, bow-tie and event tree analysis.
- Evaluation and control: risk estimation and evaluation, risk control with separate implementation and effectiveness verification, residual risk and benefit-risk analysis, and the risk management review and report.
- Production and post-production: collecting and reviewing information, and maintaining the risk management file when things change.
- Conditional modules: software, connected devices and cybersecurity, usability, biological safety, electrical equipment, and sterile, reusable, implantable and in vitro diagnostic devices, each naming the relevant device standards such as IEC 62304, IEC 62366-1, ISO 10993-1 and IEC 60601-1.
- Assessment: ISO 14971 and ISO/TR 24971 matrices, an EU MDR Annex I matrix, a gap assessment with 30-day, 60-day and 90-day plans, internal audit and management review.
Who it's for
Legal, start-up and contract manufacturers, device designers, software as a medical device developers, and medical electrical equipment and IVD manufacturers. Within them, quality, regulatory, risk, design, clinical, post-market surveillance and complaint teams use it, together with internal audit and consultants.
It pairs with the ISO 13485:2016 medical QMS toolkit, which provides the quality management system that risk management operates within. For enterprise risk rather than device risk, see the ISO 31000:2018 risk management toolkit.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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