Checklist - Regulatory Globe https://www.regulatoryglobe.com Your Regulatory Partner for Medical Devices - EU MDR and IVDR Thu, 26 Sep 2024 10:11:08 +0000 en-US hourly 1 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)

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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 ']

 

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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 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)

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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 MDSAP vs. ISO 13485:2016 Checklist https://www.regulatoryglobe.com/shop/mdsap/checklist-mdsap/?utm_source=rss&utm_medium=rss&utm_campaign=checklist-mdsap https://www.regulatoryglobe.com/shop/mdsap/checklist-mdsap/#respond Tue, 09 Oct 2018 10:39:50 +0000 https://regulatory.wptheme.ch/?post_type=product&p=279 The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and helps to track those during the implementation phase. (Based on the MDSAP Companion document AU P0002.009 - 06. August 2024)

Developed in cooperation with: 

Recommended by:  

 

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
  • The checklist supports well during the implementation
  • Helpful overview during the next MDSAP audit

 

What you get:

  • Instruction for use
  • Technical Support
  • Customer feedback improved tool

 

[button size='medium' style='' text='Test Version' icon='fa-angle-double-right' icon_color='' link='https://pages.convertkit.com/2e5f82a44d/dbe3d0e9c3' 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 MDSAP vs. ISO 13485:2016 Checklist first appeared on Regulatory Globe.

]]> Document Format:
  • Excel 2010
  • Excel 2013
  • Excel 2016

Language:

  • English

Reference Documents:

  • MDSAP Companion Document (FDA: AU P0002.009 from 06. August 2024)
  • ISO 13485:2016

The post MDSAP vs. ISO 13485:2016 Checklist first appeared on Regulatory Globe.

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