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EU AI Act Gap-Assessment Tool

Michael Galiker — Thu, 09 Oct 2025 16:18:06 +0000

This EU AI Act Gap-Assessment tool supports you to evaluate all your gaps in your Company. (Full version includes the complete EU AI Regulation EU 2024/1689)

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Download our test version today to get a first impression of how it works, and how powerful this tool can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

Significant saving of working hours
Very simple to use
Unique keyword search function
Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

Instruction for use
Technical Support
Customer feedback improved tool

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.

QSR to QMSR Gap-Assessment Tool

Michael Galiker — Mon, 04 Aug 2025 09:34:57 +0000

This QSR to QMSR Gap Assessment Tool is a cloud based tool designed to make your transition smooth, fast, and audit-ready. Developed by regulatory experts, this tool identifies all gaps between your current QSR-based system and the new QMSR—including ISO 13485 requirements and FDA-specific additions.

How it works:

Link to Video

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Benefits:

Avoid costly noncompliance
Save time with a ready-to-use compliance map
Easy to sort by specific requirements and gaps

What you get:

A clear, section-by-section gap analysis
Mapping from QSR to ISO 13485 and QMSR
Coverage of FDA-specific requirements not in ISO 13485

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.

Newsletter Advertisement – Logo

Michael Galiker — Mon, 06 Jan 2025 15:48:13 +0000

Data:

Once per week to 5’000+ Subscribers
Target Audience: Regulatory and Quality Professionals
Open Rate 40-45%

Specification:

1 Logo incl. webpage link

The post Shop first appeared on Regulatory Globe.

Newsletter Advertisement – Standard

Michael Galiker — Mon, 06 Jan 2025 15:45:31 +0000

Data:

Once per week to 5’000+ Subscribers
Target Audience: Regulatory and Quality Professionals
Open Rate 40-45%

Specification:

50 words max.
1 Picture incl. webpage link

The post Shop first appeared on Regulatory Globe.

Newsletter Advertisement – Main

Michael Galiker — Mon, 06 Jan 2025 15:24:09 +0000

Data:

Once per week to 5’000+ Subscribers
Target Audience: Regulatory and Quality Professionals
Open Rate 40-45%

Specification:

100 words max.
1 Picture incl. webpage link
1 Action Button

The post Shop first appeared on Regulatory Globe.

Elly One Year Access

Michael Galiker — Mon, 09 Dec 2024 14:45:54 +0000

Be always informed about upcoming regulations, guidances and standards!!!

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What you get:

12 Month Access
Up to date AI-powered Chatbot
Trained on global regulations of the following countries: USA, Canada, Australia, Japan, Brazil, EU (incl. member states), UK, China, India, Saudi-Arabia, Singapore, Switzerland
News Feed
Link to relevant documents
Transparent System
Technical Support

Benefits:

Improve your regulatory skills
Safe time and costs
Always up-to-date
No Language Boundaries

https://youtu.be/4XDjSIEDF_o?si=DbVZOoZi04xAzDCP

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.

MedDO / MepV Assessment Tool

Michael Galiker — Sat, 12 Jun 2021 10:56:39 +0000

This MedDO / MepV assessment tool (in German language only) supports being aligned with the Swiss MepV SR 812.213 from May 26, 2021. It additionally includes the explanation from May 19, 2021 published by the Swiss Federal Office of Public Health (FOPH).

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This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

Simple overview / No paper chaos
Easy to sort by specific county requirements

What you get:

Instruction for use
Technical Support

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.

PMCF-Plan Template

Michael Galiker — Fri, 20 Nov 2020 07:54:27 +0000

Description:

PMCF-Plan template plan according to MDCG 2020-7

Benefits:

For free

Document Format:

Word 2010
Word 2013
Word 2016

Language:

English

Reference Documents:

EU 2017/745, English version of 5 May 2017
Corrigenda, 13. March 2019
Corrigenda, 27. December 2019
Amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (24. April 2020)
MDCG 2020-7

The post Shop first appeared on Regulatory Globe.

Regulatory Intelligence Paper One Year Edition on sale

Michael Galiker — Wed, 16 Sep 2020 12:14:54 +0000

Be always informed about upcoming regulations, guidances and standards!!!

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What you get:

Receive every month for one year our Intelligence Paper - (12 editions)
Focus on all MDSAP countries (USA, Canada, Australia, Brazil, Japan), EU, UK and Switzerland
Instruction for Use
Technical Support

Benefits:

You pay only for 10 but you will receive 12 editions
Ideal to use for management review according to ISO 13485:2016, chapter 5.6
Saving you a lot of research hours
Be always informed about the latest regulatory changes
Stop being reactive and start to be proactive
Strong focus on regulations, guidances and standards
Focus on MDSAP + EU countries
Inclusive decision tree

https://www.regulatoryglobe.com/wp-content/uploads/2019/10/Regulatory-Intelligence-Paper-incl-start-bild.mp4

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.

IVDD vs IVDR Gap-Assessment Tool

Michael Galiker — Mon, 05 Aug 2019 17:38:40 +0000

This IVDD vs IVDR Gap-Assessment / Comparison Tool supports you to evaluate all your gaps in your Company. (Full version includes the complete IVDR from 20 March 2023 + Regulation EU 2024/1860 + correlation table to IVDD)

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Developed in cooperation with:

MedBoard and Regulatory Globe invested over 1000 hours to develop and optimize this IVDR vs IVDD Gap-Assessment Tool. The integrated correlation table between IVDD and IVDR will help to get a much deeper understanding of the upcoming changes and helps to reduce requirements much faster. Download our test version today to get a first impression of how it works, and how powerful this correlation table can be.

This tool is Excel-based because:

- No software installation required
- Your highly sensitive data are 100% under your control
- You do not have to trust any third parties

Benefits:

Visual correlation between IVDD and IVDR
Wording Gap-Analysis between IVDD and IVDR
Free corrigendum updates until May 2022
Significant saving of working hours
Unique keyword search function
Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

Instruction for use
Technical Support
Customer feedback improved tool

Our Payment Partners:

The post Shop first appeared on Regulatory Globe.