MDR Gap Assessment Tool – Introduction

Our Products are based on Word or Excel and designed in a way were no additional IT knowledge is needed. Just download and start!!!
Should you have any questions or require additional information, please don’t hesitate to contact me directly by mail or by phone.
This Excel version does not include the complete medical device regulation. It will give you just a brief overview of how the tool works.
This Excel version includes the complete medical device regulation (EU 2017/745, English version of 5 May 2017 + Corrigendum 1 and 2 + Postponement until May 26, 2021).
Compatible with: Excel version 2010, 2013 and 2016.
This Excel version does not include the complete medical device regulation. It will give you just a brief overview of how the tool works.
This Excel version includes the complete medical device regulation (EU 2017/745, German version of 5 May 2017 + Corrigendum 1 and 2 + Postponement until May 26, 2021).
Compatible with: Excel version 2010, 2013 and 2016.
This Excel version does not include the complete IVDR. It will give you just a brief overview of how the tool works.
This Excel version includes the complete IVDR (EU 2017/746, English version of 5 May 2017 + Corrigendum 1 and 2).
Compatible with: Excel version 2010, 2013 & 2016
This Excel version does not include the complete IVDR. It will give you just a brief overview of how the tool works.
This Excel version includes the complete IVDR (EU 2017/746, English version of 5 May 2017 + Corrigendum 1 and 2).
Compatible with: Excel version 2010, 2013 & 2016
Note: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.
This English Word Version includes the complete Annex VIII (classifiaction rules) and is the ideal template for your company. Compatible with: Word version 2010, 2013 & 2016
Buy nowNote: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.
This German Word Version includes the complete Annex VIII (classifiaction rules) and is the ideal template for your company. Compatible with: Word version 2010, 2013 & 2016
Buy nowQUNIQUE GmbH and Regulatory Globe offer you a unique Service in the following Packages:
SILVER: | Complete GAP-Analysis according to the Medical Device Regulation (MDR, EU 2017/745) or |
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GOLD: | Complete GAP-Analysis according to the Medical Device Regulation (MDR, EU 2017/745) including ISO 13485:2016 or |
PLATIN: | Complete GAP-Analysis according to the Medical Device Regulation (MDR, EU 2017/745) including MDSAP and ISO 13485:2016 |
With the help of our tool we create a GAP analyses report for you that demonstrates the gaps you have in respect of the relevant requirements.. This report can be presented to your management. Furthermore, our services encompass a Project Plan that shows the gaps and defines who is responsible to close the identified gaps. With the option to evaluate the time required to close the gaps, you can expect a document that helps you fulfill the requirements in an efficient and cost saving manner.
What to expect:
How it works: