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MDR Gap-Tool FREE VERSION (English)

This Excel version does not include the complete medical device regulation. It will give you just a brief overview of how the tool works.

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MDR Gap-Tool free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

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MDR Gap-Tool FULL VERSION (English)

This Excel version includes the complete medical device regulation (EU 2017/745, English version of 20 March 2023 + the last amendment Regulation EU 2024/1860). Compatible with: Excel version 2010, 2013, 2016 and higher.

Buy now
Click here

MDR Gap-Tool free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...
Buy now

IVDR Gap-Tool FREE VERSION (English)

This Excel version does not include the complete IVDR. It will give you just a brief overview of how the tool works.

Click here

IVDR Gap-Tool Free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...

IVDR Gap-Tool FULL VERSION (English)

This Excel version includes the complete IVDR (EU 2017/746, English version of 20 March 2023 + the last amendment Regulation EU 2024/1860). Compatible with: Excel version 2010, 2013, 2016 and higher.

Buy now
Click here

IVDR Gap-Tool Free Version (English)

If you do not opt for our News Letter, we will delete your data according to the new GDPR regulation.

You will receive important information about MDR, ISO 13485: 2016, MDSAP and our tools. You will get maximum two News Letters each month.

Please wait...
Buy now
PDF Version: Classification Form, MDR Annex VIII (English):

Note: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.

Word Version: Classification Form, MDR Annex VIII (English)

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 and higher.

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PDF Version: Classification Form, MDR Annex VIII (German):

Note: Template (Word Version) is included in the MDR Gap-Analysis FULL Version or can be downloaded below as single Word Version.

Word Version: Classification Form, MDR Annex VIII (German)

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 and higher.

Buy now