Report Scope
Identify device family, models, markets, reporting period, and regulatory context.
4.8
on G2
Free Medical Devices Template
PMS report summarizing field performance for [device_name]
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] |
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.
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 post-Market Surveillance Report.
Q: What is a post-Market Surveillance Report?
A: A post-Market Surveillance Report is a structured document for pms report summarizing field performance for [device_name].
Q: Can I download this post-Market Surveillance Report 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.