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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.
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...
QMS Templates and
Procedures
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Showing 1 - 60 out of 60
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| Document | Release Date (YYYY-MM-DD) | Market | Process | Price | Action |
|---|---|---|---|---|---|
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2025-03-10
|
Human Resources
|
500,00 €
|
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|
2025-03-10
|
Human Resources
|
Free
|
|||
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2025-03-10
|
Human Resources
|
Free
|
|||
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2025-03-10
|
Human Resources
|
Free
|
|||
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2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Human Resources
|
Free
|
|||
|
2025-03-10
|
Management Responsibility
|
Free
|
|||
|
2025-06-20
|
Communication
|
Free
|
|||
|
2025-01-14
|
Corrective and Preventive Action
|
Free
|
|||
|
2025-01-14
|
Corrective and Preventive Action
|
500,00 €
|
|||
|
2025-01-14
|
Post-Market Surveillance
|
450,00 €
|
|||
|
2025-01-14
|
Clinical Evaluation
|
500,00 €
|
|||
|
2025-01-14
|
Audit
|
500,00 €
|
|||
|
2025-03-19
|
Post-Market Surveillance
|
Free
|
|||
|
2025-01-24
|
Complaint handling
|
Free
|
|||
|
2025-01-24
|
Complaint handling
|
Free
|
|||
|
2025-01-24
|
Complaint handling
|
50,00 €
|
|||
|
2025-01-30
|
Complaint handling
|
500,00 €
|
|||
|
2025-02-05
|
Document Control
|
300,00 €
|
|||
|
2026-01-21
|
Clinical Evaluation
|
10,00 €
|
|||
|
2025-02-11
|
Document Control
|
350,00 €
|
|||
|
2026-01-21
|
Audit
|
Free
|
|||
|
2026-01-21
|
Audit
|
Free
|
|||
|
2026-01-21
|
Human Resources
|
Free
|
|||
|
2025-02-17
|
Risk Management
|
200,00 €
|
|||
|
2025-02-17
|
Risk Management
|
Free
|
|||
|
2026-01-21
|
Management
|
Free
|
|||
|
2026-01-21
|
Management
|
Free
|
|||
|
2024-12-06
|
Clinical Evaluation
|
Free
|
|||
|
2024-04-09
|
Clinical Evaluation
|
Free
|
|||
|
2024-07-03
|
Clinical Evaluation
|
Free
|
|||
|
2024-07-03
|
Clinical Evaluation
|
Free
|
|||
|
2025-08-19
|
Clinical Evaluation
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2025-02-24
|
Risk Management
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2026-01-27
|
Clinical Evaluation
|
Free
|
|||
|
2023-10-31
|
Clinical Evaluation
|
Free
|
|||
|
2024-11-29
|
Audit
|
Free
|
|||
|
2025-02-28
|
Risk Management
|
Free
|
|||
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2024-11-29
|
Audit
|
Free
|
|||
|
2024-11-29
|
Audit
|
Free
|
|||
|
2025-11-14
|
Technical Documentation
|
Free
|
|||
|
2024-11-13
|
Audit
|
Free
|
|||
|
2024-10-15
|
Corrective and Preventive Action
|
Free
|
|||
|
2024-11-06
|
Post-Market Surveillance
|
Free
|
|||
|
2024-07-31
|
Post-Market Surveillance
|
Free
|
|||
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2025-04-07
|
Design Control
|
Free
|
|||
|
2024-07-05
|
Post-Market Surveillance
|
Free
|
|||
|
2023-12-18
|
Post-Market Surveillance
|
Free
|
|||
|
2023-12-11
|
Technical Documentation
|
Free
|
|||
|
2023-10-28
|
Technical Documentation
|
Free
|
|||
|
2023-10-23
|
Technical Documentation
|
Free
|
Expert in Medical Device Compliance
