Resource Center
LEXQARA offers free templates and practical documents to help MedTech startups move forward from the earliest stages of their project. These resources are designed to be immediately useful and to create a strong foundation for the future development of your QMS, technical documentation, clinical strategy and regulatory pathway. For startups that need further support, LEXQARA also provides tailored guidance to help structure the project step by step.
Our Quality Management System documents or our Lex ebooks aim at the simplification of your daily work. Download, use, modify our templates, procedures and contact us if you need our expertise, support or training.
QMS Templates and
Procedures
Don’t take time to define your QMS documents from scratch.
| Document | Release Date (YYYY-MM-DD) | Market | Process | Price | Action |
|---|---|---|---|---|---|
| Appraisal plan | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
|
| Audit Conclusion Form | 2026-01-21 | Europe | Audit | Free |
|
| Audit Plan Form | 2024-11-29 | Worldwide | Audit | Free |
|
| Audit Procedure | 2025-01-14 | Worldwide | Audit | 500,00 € |
|
| Audit Program | 2024-11-13 | Worldwide | Audit | Free |
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| Audit Report Form | 2024-11-29 | Worldwide | Audit | Free |
|
| Clinical data search protocol | 2023-10-31 | Worldwide | Clinical Evaluation | Free |
|
| Clinical evaluation plan | 2024-07-03 | Europe | Clinical Evaluation | Free |
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| Clinical Evaluation Procedure | 2025-01-14 | Europe | Clinical Evaluation | 500,00 € |
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| Clinical evaluation report | 2025-08-19 | Europe | Clinical Evaluation | Free |
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| Competence Matrix | 2025-03-10 | Europe | Human Resources | Free |
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| Complaint Form | 2025-01-24 | Worldwide | Complaint handling | Free |
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| Complaint Handling Procedure | 2025-01-30 | Europe | Complaint handling | 500,00 € |
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| Complaint Log | 2025-01-24 | Worldwide | Complaint handling | Free |
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| Corrective and Preventive Action Form | 2024-10-15 | Worldwide | Corrective and Preventive Action | Free |
|
| Corrective and Preventive Action Log | 2025-01-14 | Worldwide | Corrective and Preventive Action | Free |
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| Corrective and Preventive Action Procedure | 2025-01-14 | Worldwide | Corrective and Preventive Action | 500,00 € |
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| Data screening & extraction tool | 2024-07-03 | Europe | Clinical Evaluation | Free |
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| Declaration of conformity | 2023-12-11 | Europe | Technical Documentation | Free |
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| Declaration of Interest | 2024-12-06 | Europe | Clinical Evaluation | Free |
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| Design and Development Planning Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Change Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Control Pack | 2026-03-31 | Europe | Design Control | Free |
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| Design Control Procedure | 2026-03-31 | Europe | Design Control | Free |
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| Design Inputs Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Review Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Transfer Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Verification & Validation Test Protocol Form | 2026-03-31 | Europe | Design Control | Free |
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| Design Verification & Validation Test Report Form | 2026-03-31 | Europe | Design Control | Free |
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| DHF Form | 2026-03-31 | Europe | Design Control | Free |
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| Document Control Procedure | 2025-02-05 | Europe | Document Control | 300,00 € |
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| Document Training Form | 2025-03-10 | Europe | Human Resources | Free |
|
| Employee Qualification Records | 2025-03-10 | Europe | Human Resources | Free |
|
| EU Regulatory Strategy Report | 2025-11-14 | Europe | Technical Documentation | Free |
|
| External Audit Finding Log | 2026-01-21 | Europe | Audit | Free |
|
| Human Resources Procedure | 2025-03-10 | Europe | Human Resources | 500,00 € |
|
| IVDR GSPR checklist | 2023-10-28 | Europe | Technical Documentation | Free |
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| Job Description Form | 2025-03-10 | Europe | Human Resources | Free |
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| Literature search report for AC | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
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| Literature search report for S&P | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
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| Literature search report for SoA | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
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| Matrix of Independence | 2026-01-21 | Europe | Human Resources | Free |
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| MDR Audit Checklist | 2024-11-29 | Europe | Audit | Free |
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| MDR GSPR checklist | 2023-10-23 | Europe | Technical Documentation | Free |
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| MDR Vigilance Reporting SOP | 2025-01-24 | Europe | Complaint handling | 50,00 € |
|
| Periodic Safety Update Report (PSUR) | 2024-07-31 | Europe | Post-Market Surveillance | Free |
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| PMCF Evaluation Report | 2024-07-05 | Europe | Post-Market Surveillance | Free |
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| PMCF plan | 2023-12-18 | Europe | Post-Market Surveillance | Free |
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| PMCF Procedure | 2025-01-14 | Europe | Post-Market Surveillance | 450,00 € |
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| PMS Plan | 2026-03-30 | Europe | Post-Market Surveillance | Free |
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| Quality Objectives Form | 2026-01-21 | Europe | Management | Free |
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| Record Control Procedure | 2025-02-11 | Europe | Document Control | 350,00 € |
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| Register of signatures | 2025-03-10 | Europe | Human Resources | Free |
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| Report on existing literature & literature gap search | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
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| Risk Analysis Form | 2025-02-24 | Europe | Risk Management | Free |
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| Risk Management Plan Form | 2025-02-17 | Europe | Risk Management | Free |
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| Risk Management Procedure | 2025-02-17 | Europe | Risk Management | 200,00 € |
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| Risk Management Report | 2025-02-28 | Europe | Risk Management | Free |
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| Role and Responsibilities Matrix | 2025-03-10 | Europe | Management Responsibility | Free |
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| Search report for vigilance / recall | 2026-01-27 | Worldwide | Clinical Evaluation | Free |
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| SSCP Readability Validation Report | 2026-01-21 | Europe | Clinical Evaluation | 10,00 € |
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| Strategic Quality Plan Form | 2026-01-21 | Europe | Management | Free |
|
| Structured Dialogue Cover Letter | 2025-06-20 | Europe | Communication | Free |
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| Summary of Safety and Clinical Performance (SSCP) | 2024-04-09 | Europe | Clinical Evaluation | Free |
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| Traceability Matrix | 2025-04-07 | Europe | Design Control | Free |
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| Training Attendance Sheet | 2025-03-10 | Europe | Human Resources | Free |
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| Training Plan Form | 2025-03-10 | Europe | Human Resources | Free |
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| Training Program | 2025-03-10 | Europe | Human Resources | Free |
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| Training Record Form | 2025-03-10 | Europe | Human Resources | Free |
|
| Trend Analysis Tool | 2024-11-06 | Worldwide | Post-Market Surveillance | Free |
|
| User Requirements Form | 2026-03-31 | Europe | Design Control | Free |
|
Lex Book
Understand the requirements, get the right recommendations, download without moderation our Lex ebooks.
April 10th, 2025
Overall medical device requirements in Great Britain (GB)
Description:
This ebook summarizes the Great Britain pathway for placing medical devices on the market,...
October 18th, 2023
MDR Regulatory pathway for medical device
Description:
This ebook maps the MDR regulatory pathways by device class so we can choose the right...
October 12th, 2023
MDR classification for devices composed of substances
Description:
This ebook guides how to determine whether a product is a medical device “with substances”...
December 19th, 2023
Annex XVI devices without medical purpose
This ebook explains how to qualify, classify, and transition Annex XVI devices under the MDR, including...
Expert in Medical Device Compliance
