Device and Scope
Identify device, lifecycle phase, intended use, users, use environments, and included accessories or software.
4.8
on G2
Free Medical Devices Template
Download a free risk management file template in Word, PDF, or Markdown. Or turn any video into risk management file template with Docsie AI — auto-fills every required field.
Use this template to iSO 14971 risk file summary for [device_name].
| Field | Details |
|---|---|
| Category | Medical Devices |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |
Identify device, lifecycle phase, intended use, users, use environments, and included accessories or software.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Define severity, probability, risk acceptability, and benefit-risk escalation criteria.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
List hazards, foreseeable sequences of events, hazardous situations, harms, and initial risk ratings.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Document inherent safety, protective measures, information for safety, verification, and residual risk.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Explain any unacceptable residual risks and clinical or user benefits supporting acceptability.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Summarize overall residual risk evaluation and labeling implications.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Describe post-production monitoring, complaint review, PMS inputs, and triggers for risk file updates. Use ISO 14971-style terminology and include risk tables.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Document review conclusions, approvals, unresolved items, and next review date.
| Role | Name | Date | Notes |
|---|---|---|---|
| Preparer | [Name] | [Date] | [Notes] |
| Reviewer | [Name] | [Date] | [Notes] |
| Approver | [Name] | [Date] | [Notes] |
Deploy this template during initial device development, design changes, or when preparing regulatory submissions requiring ISO 14971 compliance.
This template produces a complete ISO 14971-compliant risk management file documenting hazards, controls, and benefit-risk evaluations throughout device lifecycle.
Teams often create incomplete risk files by skipping critical sections or failing to link controls back to specific hazards.
Template Structure
Use this medical devices template as a starting point, then customize each section to match your internal workflow, evidence, and signoff needs.
Identify device, lifecycle phase, intended use, users, use environments, and included accessories or software.
Define severity, probability, risk acceptability, and benefit-risk escalation criteria.
List hazards, foreseeable sequences of events, hazardous situations, harms, and initial risk ratings.
Document inherent safety, protective measures, information for safety, verification, and residual risk.
Explain any unacceptable residual risks and clinical or user benefits supporting acceptability.
Summarize overall residual risk evaluation and labeling implications.
Describe post-production monitoring, complaint review, PMS inputs, and triggers for risk file updates. Use ISO 14971-style terminology and include risk tables.
Write a Medical Device Risk Management File. Structure with these Markdown sections:
Identify device, lifecycle phase, intended use, users, use environments, and included accessories or software.
Define severity, probability, risk acceptability, and benefit-risk escalation criteria.
List hazards, foreseeable sequences of events, hazardous situations, harms, and initial risk ratings.
Document inherent safety, protective measures, information for safety, verification, and residual risk.
Explain any unacceptable residual risks and clinical or user benefits supporting acceptability.
Summarize overall residual risk evaluation and labeling implications.
Describe post-production monitoring, complaint review, PMS inputs, and triggers for risk file updates.
Use ISO 14971-style terminology and include risk tables.
This file covers sterile single-use infusion set IS-40 and clamp accessory.
Severity S4 events require documented risk control verification and management review.
| Hazard | Sequence | Harm | Initial Risk |
|---|---|---|---|
| Flow occlusion | Kinked tubing not detected | Under-infusion | High |
Tubing wall thickness was increased and IFU warnings were revised.
No unacceptable residual risks remain after verified controls.
Overall residual risk is acceptable with current labeling.
Complaints are trended monthly for occlusion and leakage codes.
Already have a walkthrough or training video covering this process? Skip manual drafting. Upload the video and Docsie AI generates risk management file template with every required field populated — ready for review, signoff, or export.
Use the template manually, or let Docsie generate the first draft from source footage.
Procedure for receiving and investigating device complaints
DHF summary for [device_name] and design control evidence
Report validating [device_name] meets user needs and intended use
Protocol verifying [device_name] design outputs against design inputs
FSCA plan and notice for [device_issue]
IQ protocol for installing [equipment_or_system] used in device production
Template FAQ
Common questions about downloading and generating a risk management file template.
Q: What is a risk management file template?
A: A risk management file template is a structured document for iso 14971 risk file summary for [device_name].
Q: Is the risk management file template really free?
A: Yes. The risk management file template is completely free to download in Word (DOCX), PDF, and Markdown formats. No signup or credit card required to download.
Q: How do I turn a video into a risk Management File?
A: Upload a process walkthrough, training recording, or screen capture to Docsie. The AI analyzes the video and generates a complete risk Management File using this template's structure — every required field auto-filled from the footage.
Q: Can I edit the risk management file template after downloading?
A: Yes. The DOCX format opens in Microsoft Word or Google Docs. The Markdown format imports into Notion, Confluence, Docsie, or any markdown editor. Customize fields, add your branding, and adapt to your internal workflow.