Report Scope
Identify device family, models, markets, reporting period, and regulatory context.
4.8
on G2
Free Medical Devices Template
Download a free post-market surveillance report template in Word, PDF, or Markdown. Or turn any video into post-market surveillance report template with Docsie AI — auto-fills every required field.
Use this template to pMS report summarizing field performance 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 family, models, markets, reporting period, and regulatory context.
| 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 complaints, service data, vigilance reports, literature, registries, surveys, and production feedback reviewed.
| 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 units distributed, active installed base, patient exposure, or procedure volume.
| 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.]
Present complaint rates, serious incidents, malfunctions, and nonconformance signals.
| 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.]
Compare current rates to thresholds, prior periods, and known risks.
| 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.]
State whether PMS data changes risk estimates, controls, labeling, or benefit-risk conclusions.
| 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 safety and performance conclusions, actions, and next reporting period. Use objective surveillance language and include rates where possible.
| 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 when fulfilling periodic post-market surveillance obligations under ISO 13485, MDR, or FDA guidance.
This template produces a complete surveillance report linking field data to risk management and regulatory compliance.
Most teams undermine surveillance credibility by omitting denominators, cherry-picking data, or skipping risk file linkage.
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 family, models, markets, reporting period, and regulatory context.
List complaints, service data, vigilance reports, literature, registries, surveys, and production feedback reviewed.
Summarize units distributed, active installed base, patient exposure, or procedure volume.
Present complaint rates, serious incidents, malfunctions, and nonconformance signals.
Compare current rates to thresholds, prior periods, and known risks.
State whether PMS data changes risk estimates, controls, labeling, or benefit-risk conclusions.
Summarize safety and performance conclusions, actions, and next reporting period. Use objective surveillance language and include rates where possible.
Write a Medical Device Post-Market Surveillance Report. Structure with these Markdown sections:
Identify device family, models, markets, reporting period, and regulatory context.
List complaints, service data, vigilance reports, literature, registries, surveys, and production feedback reviewed.
Summarize units distributed, active installed base, patient exposure, or procedure volume.
Present complaint rates, serious incidents, malfunctions, and nonconformance signals.
Compare current rates to thresholds, prior periods, and known risks.
State whether PMS data changes risk estimates, controls, labeling, or benefit-risk conclusions.
Summarize safety and performance conclusions, actions, and next reporting period.
Use objective surveillance language and include rates where possible.
Covers CardioPatch CP-2 devices distributed in the US and EU from Q1 to Q2 2026.
Sources included complaints, service tickets, vigilance database searches, and literature review.
42,800 devices were distributed with an estimated 39,600 patient uses.
Skin irritation complaints occurred at 0.18%, below the 0.40% alert threshold.
No statistically significant increase was observed for adhesion failure.
No risk file update is required for this period.
The device continues to meet expected safety and performance criteria.
Already have a walkthrough or training video covering this process? Skip manual drafting. Upload the video and Docsie AI generates post-market surveillance report 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 post-market surveillance report template.
Q: What is a post-market surveillance report template?
A: A post-market surveillance report template is a structured document for pms report summarizing field performance for [device_name].
Q: Is the post-market surveillance report template really free?
A: Yes. The post-market surveillance report 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 post-Market Surveillance Report?
A: Upload a process walkthrough, training recording, or screen capture to Docsie. The AI analyzes the video and generates a complete post-Market Surveillance Report using this template's structure — every required field auto-filled from the footage.
Q: Can I edit the post-market surveillance report 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.