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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.

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Overall medical device requirements in Great Britain (GB)
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...
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MDR Regulatory pathway for medical device
October 18th, 2023
MDR Regulatory pathway for medical device
In Europe, manufacturers of medical devices have various options of conformity assessment procedures...
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MDR classification for devices composed of substances
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....
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Annex XVI devices without medical purpose
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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QMS Templates and
Procedures

Don’t take time to define your QMS documents from scratch.

Documents
Market
Document Release date
(MM-DD-YYYY) Document number Market
Quality documents
Audit Program
11-13-2024
FORM-AUD-001 rev.1
World-Wide
Download
Corrective and Preventive Action Form
10-15-2024
FORM-CAPA-001 rev.1
World-Wide
Download
Post-Market documents
Trend Analysis Tool
11-06-2024
TOOL-PMS-001 rev.1
World-Wide
Download
Periodic Safety Update Report (PSUR)
07-31-2024
LEX-FORM-EU-015 rev.1
Europe
Download
PMCF Evaluation Report
07-05-2024
LEX-FORM-EU-017 rev.1
Europe
Download
PMCF plan
12-18-2023
LEX-FORM-EU-014 rev.1
Europe
Download
PMS plan
12-12-2023
LEX-FORM-EU-013 rev.1
Europe
Download
Clinical documents
Summary of Safety and Clinical Performance (SSCP)
04-09-2024
LEX-FORM-EU-011 rev.1
Europe
Download
Data screening & extraction tool
07-03-2024
LEX-TOOL-CER-001
Europe
Download
Clinical evaluation plan
07-03-2024
LEX-FORM-EU-012 rev.2
Europe
Download
Clinical evaluation report
07-03-2024
LEX-FORM-EU-003 rev.1
Europe
Download
Appraisal plan
11-02-2023
LEX-FORM-EU-010 rev.1
World-Wide
Download
Report on existing literature & literature gap search
11-02-2023
LEX-FORM-EU-009 rev.1
World-Wide
Download
Search report for vigilance / recall
11-02-2023
LEX-FORM-EU-008 rev.1
World-Wide
Download
Literature search report for AC
11-02-2023
LEX-FORM-EU-007 rev.1
World-Wide
Download
Literature search report for SoA
11-02-2023
LEX-FORM-EU-006 rev.1
World-Wide
Download
Literature search report for S&P
11-02-2023
LEX-FORM-EU-005 rev.1
World-Wide
Download
Clinical data search protocol
10-31-2023
LEX-FORM-EU-004 rev.1
World-Wide
Download
Regulatory documents
Declaration of conformity
12-11-2023
LEX-FORM-EU-018 rev.1
Europe
Download
IVDR GSPR checklist
10-28-2023
LEX-FORM-EUIVDR-002 rev.1
Europe
Download
MDR GSPR checklist
10-23-2023
LEX-FORM-EU-002 rev.1
Europe
Download
Regulatory Pathway Report
10-19-2023
LEX-FORM-WW-001 rev.1
Europe
Download
Regulatory Strategy Documents
Regulatory Pathway Report
10-19-2023
LEX-FORM-WW-001 rev.1
Europe
Download

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