Clinical evaluation
Clinical Evaluation Plan
Define device scope, clinical objectives, evidence needs and evaluation methods before you begin.
Word (.docx) · Editable template
Download templateThe Bevrik resource library
Spend less time starting from scratch.
Practical templates and checklists to help your team organize evidence, document decisions and keep regulatory work moving.
Articles & guides
Ideas for the work behind the evidence.
Explore practical perspectives on medical device AI, clinical evidence, risk and post-market monitoring.
Explore articles & guidesDocument templates
A clearer starting point for your next document.
Download available templates below. More documents will be added as they become available.
The Word templates are editable EU MDR authoring frameworks, not completed or approved reports. Confirm applicability and current guidance, add your device-specific evidence, and complete your own clinical, regulatory and quality review before use.
Clinical evaluation
Clinical Evaluation Report
Organize appraised evidence, clinical findings, benefit–risk conclusions and remaining evidence gaps.
Word (.docx) · Editable template
Download templatePost-market surveillance
PMS Plan
Plan data collection, signal review, trend analysis, responsibilities and reporting schedules.
Word (.docx) · Editable template
Download templatePost-market clinical follow-up
PMCF Plan
Define follow-up questions, activities, endpoints and timelines for continued clinical evaluation.
Word (.docx) · Editable template
Download templatePost-market surveillance
Periodic Safety Update Report
Bring together surveillance findings, exposure estimates, safety signals and benefit–risk conclusions.
Word (.docx) · Editable template
Download templateRisk management
Risk Assessment Template
Connect hazards and harms to risk controls, implementation evidence and effectiveness checks.
Excel (.xlsx) · Editable workbook
Download templateRequirements & compliance
GSPR Checklist
Record applicability, explain your decisions and link each requirement to supporting evidence.
Planned Excel workbook · Coming soon
Requirements & compliance
Standards Compliance Matrix
Map requirements to implementation evidence, with space for applicability and justification.
Planned Excel workbook · Coming soon
Supporting tools
Small tools for the work in between.
Find supporting documents, quick-reference sheets, logs and focused worksheets in one easy-to-scan list. Download available files below; more tools will be added as they become available.
Scroll across the table to see all details.
| Tool | Use it to | Format | Download |
|---|---|---|---|
| Summary of Safety and Clinical Performance (SSCP) v1.1 | Structure professional and patient-facing summaries of device benefits, risks, evidence and alternatives. | Word (.docx) | Download |
| PMCF Evaluation Report v1.1 | Compare planned activities with actual results and document their impact on clinical and risk records. | Word (.docx) | Download |
| Literature Search Strategy | Define your questions, databases, search terms and screening criteria before you start. | Word (.docx) | Coming soon |
| Data Drift Monitoring Template v2 | Track data drift monitoring activities and review results in an editable Excel workbook. | Excel (.xlsx) | Download |
| Concept Drift Assessment Template | Document concept drift assessments in an editable Excel workbook. | Excel (.xlsx) | Download |
Templates and tools are starting points, not regulatory advice or a guarantee of compliance. Adapt each document to your device and applicable requirements, and have your qualified team review it before use.
From research to your next step
Continue with your task.
Read a practical guide, find a starting document and explore how Bevrik supports the work.
Prepare your next clinical evaluation
Find guidance, organize your evidence needs and explore a connected clinical workflow.
Understand
Explore clinical evaluation articles →Start
Clinical Evaluation Plan template →Manage
Explore Clinical Evaluation →
Review risks and supporting evidence
Start with the assessment, then connect controls and requirements to the evidence behind them.
Understand
Read about performance thresholds and risk →Start
Risk Assessment Template →Manage
Explore Risk Management →- Explore GSPR & Standards →
Plan monitoring after launch
Explore changing data, follow-up questions and the records your team needs to maintain.
Understand
Read the data drift guide →Start
Data Drift Monitoring Template →Manage
Discuss your post-market workflow →
Start with one recurring task
Go beyond the blank template.
Pick the task that takes too much preparation. Walk through the Bevrik approach, confirm the available workflow and identify the review your team would still need to do.