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
ISO 14971 risk file summary for [device_name]
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] |
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.
Record a walkthrough, training session, or process demonstration. Docsie AI turns it into structured documentation using this template as the starting framework.
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 using and generating a risk Management File.
Q: What is a risk Management File?
A: A risk Management File is a structured document for iso 14971 risk file summary for [device_name].
Q: Can I download this risk Management File as Word or PDF?
A: Yes. This page includes free downloads in DOCX, PDF, and Markdown formats so you can edit, share, or import the template into your documentation system.
Q: Can Docsie generate this from a video?
A: Yes. Upload a process walkthrough, training recording, or screen capture to Docsie, then use this template structure to generate a first draft automatically.