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November 12th, 2024
Overall medical device requirements in Great Britain (GB)
United Kingdom is composed of the Great Britain and the North of Ireland. This Lex ebook describes the...
October 18th, 2023
MDR Regulatory pathway for medical device
In Europe, manufacturers of medical devices have various options of conformity assessment procedures...
October 12th, 2023
MDR classification for devices composed of substances
In Europe under MDR, devices can be composed of substances that are considered medicinal substances....
December 19th, 2023
Annex XVI devices without medical purpose
In Europe, some medical devices without medical purpose fall in scope of the MDR. Since the publication...
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| Document | Release Date (YYYY-MM-DD) | Market | Process | Price | Action |
|---|---|---|---|---|---|
|
Regulatory Pathway Report
|
2023-10-19
|
Technical Documentation
|
Free
|
||
|
Corrective and Preventive Action Log
|
2025-01-14
|
Corrective and Preventive Action
|
Free
|
||
|
Corrective and Preventive Action Procedure
|
2025-01-14
|
Corrective and Preventive Action
|
500,00 €
|
||
|
PMCF Procedure
|
2025-01-14
|
Post-Market Surveillance
|
450,00 €
|
||
|
Clinical Evaluation Procedure
|
2025-01-14
|
Clinical Evaluation
|
500,00 €
|
||
|
Audit Procedure
|
2025-01-14
|
Audit
|
500,00 €
|
||
|
Declaration of Interest
|
2024-12-06
|
Clinical Evaluation
|
Free
|
||
|
Summary of Safety and Clinical Performance (SSCP)
|
2024-04-09
|
Clinical Evaluation
|
Free
|
||
|
Data screening & extraction tool
|
2024-07-03
|
Clinical Evaluation
|
Free
|
||
|
Clinical evaluation plan
|
2024-07-03
|
Clinical Evaluation
|
Free
|
||
|
Clinical evaluation report
|
2024-07-03
|
Clinical Evaluation
|
Free
|
||
|
Appraisal plan
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Report on existing literature & literature gap search
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Search report for vigilance / recall
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Literature search report for AC
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Literature search report for SoA
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Literature search report for S&P
|
2023-11-02
|
Clinical Evaluation
|
Free
|
||
|
Clinical data search protocol
|
2023-10-31
|
Clinical Evaluation
|
Free
|
||
|
MDR Audit Checklist
|
2024-11-29
|
Audit
|
Free
|
||
|
Audit Report Form
|
2024-11-29
|
Audit
|
Free
|
||
|
Audit Plan Form
|
2024-11-29
|
Audit
|
Free
|
||
|
Audit Program
|
2024-11-13
|
Audit
|
Free
|
||
|
Corrective and Preventive Action Form
|
2024-10-15
|
Corrective and Preventive Action
|
Free
|
||
|
Trend Analysis Tool
|
2024-11-06
|
Post-Market Surveillance
|
Free
|
||
|
Periodic Safety Update Report (PSUR)
|
2024-07-31
|
Post-Market Surveillance
|
Free
|
||
|
PMCF Evaluation Report
|
2024-07-05
|
Post-Market Surveillance
|
Free
|
||
|
PMCF plan
|
2023-12-18
|
Post-Market Surveillance
|
Free
|
||
|
Declaration of conformity
|
2023-12-11
|
Technical Documentation
|
Free
|
||
|
IVDR GSPR checklist
|
2023-10-28
|
Technical Documentation
|
Free
|
||
|
MDR GSPR checklist
|
2023-10-23
|
Technical Documentation
|
Free
|
Expert in Medical Device Compliance
