MDR - Regulatory Globe https://www.regulatoryglobe.com Your Regulatory Partner for Medical Devices - EU MDR and IVDR Wed, 21 Aug 2024 19:59:48 +0000 en-US hourly 1 PMCF-Plan Template https://www.regulatoryglobe.com/shop/mdr/pmcf-plan-template/?utm_source=rss&utm_medium=rss&utm_campaign=pmcf-plan-template https://www.regulatoryglobe.com/shop/mdr/pmcf-plan-template/#respond Fri, 20 Nov 2020 07:54:27 +0000 https://www.regulatoryglobe.com/?post_type=product&p=8962 PMS-Plan template according to MDCG 2020-7

Benefits:

  • For free

 

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The post PMCF-Plan Template first appeared on Regulatory Globe.

]]> 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 PMCF-Plan Template first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/pmcf-plan-template/feed/ 0 MDD vs MDR Gap-Assessment Tool https://www.regulatoryglobe.com/shop/mdr/mdd-vs-mdr-gap-assessment-tool/?utm_source=rss&utm_medium=rss&utm_campaign=mdd-vs-mdr-gap-assessment-tool https://www.regulatoryglobe.com/shop/mdr/mdd-vs-mdr-gap-assessment-tool/#respond Mon, 22 Jul 2019 21:43:30 +0000 https://www.regulatoryglobe.com/?post_type=product&p=2132 This MDD vs MDR Gap-Assessment tool includes additional to the gap-assessment section also a correlation table from MDD to MDR. This supports you to evaluate all your gaps in your Company. (Full version includes the complete MDR of 20 March 2023 + Regulation EU 2024/1860 + correlation table to MDD)

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/81dea262b8/3ba05bcef8' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

 

Developed in cooperation with: 

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MedBoard and Regulatory Globe invested over 1000 hours to develop and optimize this MDR vs MDD Gap-Assessment Tool. The integrated correlation table between MDD and MDR 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 MDD and MDR
  • Wording Gap-Analysis between MDD and MDR
  • Free corrigendum updates until May 2021
  • Significant saving of working hours
  • Unique keyword search function
  • Complete table of content (Chapter, Annexes, incl. all articles)

What you get:

  • Methodology of how to reduce requirements
  • Instruction for use
  • Technical Support
  • Customer feedback improved tool

 

Our Payment Partners:

The post MDD vs MDR Gap-Assessment Tool first appeared on Regulatory Globe.

]]> Description:

This Gap-Assessment Tool has included the complete MDR EU2017/745 and a comparison table to the MDD 93/42/EEC. Therefore, this tool is very helpful for all Medical Devices companies which have to change from MDD to MDR.

In cooperation with MedBoard Company Ltd.

Benefits:

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

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016
  • Excel 2019
  • Excel 2021

Language:

  • English

Reference Documents:

  • EU 2017/745, English version of 20 March 2023
  • Inclusive Regulation EU 2024/1860
  • MDD 93/42/EEC

The post MDD vs MDR Gap-Assessment Tool first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/mdd-vs-mdr-gap-assessment-tool/feed/ 0 MDR vs IVDR Comparison Table https://www.regulatoryglobe.com/shop/mdr/mdr-vs-ivdr-comparison-table/?utm_source=rss&utm_medium=rss&utm_campaign=mdr-vs-ivdr-comparison-table https://www.regulatoryglobe.com/shop/mdr/mdr-vs-ivdr-comparison-table/#respond Sat, 26 Jan 2019 14:05:50 +0000 https://www.regulatoryglobe.com/?post_type=product&p=858 This table compares the MDR vs. IVDR and shows where exactly the same requirements are required.

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/fe5edd9e5b/87129abc9f' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

 

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The post MDR vs IVDR Comparison Table first appeared on Regulatory Globe.

]]> Description:

This table compares the MDR vs IVDR and shows where exactly the same requirements are required.

Benefits:

  • Very useful overview
  • Very simple to use

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016

Language:

  • English

Reference Documents:

  • EU 2017/745, English version of 5 May 2017
  • EU 2017/746, English version of 5 May 2017
  • Corrigenda, 13th March 2019 of MDR and IVDR
  • Corrigenda, 27th December 2019 of MDR and IVDR

 

The post MDR vs IVDR Comparison Table first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/mdr-vs-ivdr-comparison-table/feed/ 0 MDR Gap-Assessment Tool incl. ISO 13485:2016 https://www.regulatoryglobe.com/shop/iso-13485-2016/mdr-gap-assessment-tool-incl-iso-134852016/?utm_source=rss&utm_medium=rss&utm_campaign=mdr-gap-assessment-tool-incl-iso-134852016 https://www.regulatoryglobe.com/shop/iso-13485-2016/mdr-gap-assessment-tool-incl-iso-134852016/#respond Tue, 09 Oct 2018 12:23:49 +0000 https://regulatory.wptheme.ch/?post_type=product&p=312 This MDR Gap-Assessment tool is ideal to use if you have the ISO 13485:2016 already in place and would like to integrate the MDR on top. (Full version includes the complete MDR of 20 March 2024 + Regulation EU 2024/1860 + ref. to all affected ISO chapters)

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/e015f06bdc/531595b7a0' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Developed in cooperation with: 

 

QUNIQUE and Regulatory Globe invested over 1000 hours to develop and optimize this MDR Gap-Assessment Tool incl ISO 13485:2016 references. The integrated reference table helps to find the MDR impacts on your QMS immediately. 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:

  • Reference table to ISO 13485:2016
  • Including a Gap-Report
  • Including a Project-Plan
  • Free corrigendum updates until May 2021
  • 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 MDR Gap-Assessment Tool incl. ISO 13485:2016 first appeared on Regulatory Globe.

]]> Description:

This MDR Gap-Assessment tool is very helpful when you already have the ISO 13485:2016 in place.

Benefit:

  • Comparison table between ISO 13485:2016 and MDR
  • Including a Gap-Report
  • Including a Project-Plan
  • Economic Operators search function included
  • Complete table of content of MDR (Chapter, Annexes, incl. all articles)
  • Significant saving of working hours
  • Unique keyword search function

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016
  • Excel 2019
  • Excel 2021

Language:

  • English

Reference Documents:

  • ISO 13485:2016
  • EU 2017/745, English version of 20 March 2023
  • Inclusive Regulation EU 2024/1860

The post MDR Gap-Assessment Tool incl. ISO 13485:2016 first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/iso-13485-2016/mdr-gap-assessment-tool-incl-iso-134852016/feed/ 0 General Safety and Performance Checklist https://www.regulatoryglobe.com/shop/mdr/general-safety-and-performance-checklist/?utm_source=rss&utm_medium=rss&utm_campaign=general-safety-and-performance-checklist https://www.regulatoryglobe.com/shop/mdr/general-safety-and-performance-checklist/#respond Tue, 09 Oct 2018 12:21:19 +0000 https://regulatory.wptheme.ch/?post_type=product&p=311 This checklist supports you to show conformity according to Annex I of MDR (EU) 2017/745 incl. a table of all essential standards of EU. 

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/37454b8efb/cb96d8a420' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

 

Our Payment Partners:

The post General Safety and Performance Checklist first appeared on Regulatory Globe.

]]> Description:

Includes the complete Annex I (General safety and performance) of EU MDR 2017/745  and helps to show conformity.

Benefit:

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, 25. November 2019
  • Standard update 2021 and 2022

The post General Safety and Performance Checklist first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/general-safety-and-performance-checklist/feed/ 0 EU MDR Gap-Assessment Tool https://www.regulatoryglobe.com/shop/mdr/mdr-gap-assessment-tool-eu-2017-745-medical-device-regulation/?utm_source=rss&utm_medium=rss&utm_campaign=mdr-gap-assessment-tool-eu-2017-745-medical-device-regulation https://www.regulatoryglobe.com/shop/mdr/mdr-gap-assessment-tool-eu-2017-745-medical-device-regulation/#respond Tue, 09 Oct 2018 12:11:10 +0000 https://regulatory.wptheme.ch/?post_type=product&p=310 This MDR Gap-Assessment tool supports you to evaluate all your gaps in your Company. (Full version includes the complete MDR of 20 March 2023 + Regulation EU 2024/1860)

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/2e4f952fef/dad17860c1' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Recommended by: 

 

In the last 3 years, we invested over 600 hours to develop and optimize our MDR Gap-Assessment Tool to have one of the best tools in the medical device space. This MDR Gap-Assessment Tool is actively used in over 25 countries by several hundred users and we are sure, it will help you too! 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

How it works:

[video width="1280" height="720" mp4="https://www.regulatoryglobe.com/wp-content/uploads/2019/05/MDR-IVDR-Tool-how-does-it-work.mp4"][/video]

 

Our Payment Partners:

The post EU MDR Gap-Assessment Tool first appeared on Regulatory Globe.

]]> Description:

Includes the complete MDR EU2017/745  and helps to assess your gaps.

Benefits:

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

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016
  • Excel 2019
  • Excel 2021

Language:

  • English

Reference Documents:

  • EU 2017/745, English version of 20 March 2023
  • Inclusive Regulation EU 2024/1860

The post EU MDR Gap-Assessment Tool first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/mdr-gap-assessment-tool-eu-2017-745-medical-device-regulation/feed/ 0 Economic Operators Checklist https://www.regulatoryglobe.com/shop/mdr/economic-operators-checklist/?utm_source=rss&utm_medium=rss&utm_campaign=economic-operators-checklist https://www.regulatoryglobe.com/shop/mdr/economic-operators-checklist/#respond Tue, 09 Oct 2018 11:00:17 +0000 https://regulatory.wptheme.ch/?post_type=product&p=282 Evaluate your responsible roles as Economic Operator (Manufacturer, Authorized Representative, Distributor and Importer)

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/ab0604e9cb/a0e1157149' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

Developed in cooperation with: 

 

Our Payment Partners:

The post Economic Operators Checklist first appeared on Regulatory Globe.

]]> Description:

Helps to sort according to the main requirements of the respective economic operators.

Benefit:

  • Simple and easy to use

Document Format:

  • Excel 2010
  • Excel 2013
  • Excel 2016

Language:

  • English

Reference Documents:

  • EU MDR 2017/745, English version of 5 May 2017
  • Corrigenda, 13. March 2019
  • Corrigenda, 25. November 2019
  • Amending Regulation (EU) MDR 2017/745 on medical devices, as regards the dates of application of certain of its provisions (24. April 2020)

The post Economic Operators Checklist first appeared on Regulatory Globe.

]]> https://www.regulatoryglobe.com/shop/mdr/economic-operators-checklist/feed/ 0 Classification / MDR https://www.regulatoryglobe.com/shop/mdr/classification/?utm_source=rss&utm_medium=rss&utm_campaign=classification https://www.regulatoryglobe.com/shop/mdr/classification/#respond Tue, 09 Oct 2018 10:49:19 +0000 https://regulatory.wptheme.ch/?post_type=product&p=281 Classification form according to Annex VIII of MDR (EU) 2017/745.

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/8737d62f6d/4f13e806a9' target='_blank' color='' hover_color='' border_color='' hover_border_color='' background_color='' hover_background_color='' font_style='' font_weight='' text_align='center' margin='0 25 0 0 ']

 

Our Payment Partners:

The post Classification / MDR first appeared on Regulatory Globe.

]]> Description:

Includes the complete Annex VIII (classification rules) of EU MDR 2017/745  and helps to classify your devices.

Benefit:

  • Just download and start

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, 25. November 2019

The post Classification / MDR first appeared on Regulatory Globe.

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