MDR Gap Assessment Tool – Introduction

MDR ToolMy name is Michael Galliker and in January 2017 I finished my Master of Advanced Studies in-MedTec. In context with my master thesis (master thesis of the year 2017, Bern University) and my experience in regulatory affairs I have developed a gap analysis tool which helps to implement the new medical device regulation (MDR) into the company I’m working for. As you are aware, the European medical device industry will undergo significant change as a result of the new medical device regulation which is currently finalised since May 26th, 2017. As the name suggests, it is a regulation and no longer a directive and all medical device companies have to adhere to this new regulation. Companies not following the new rules will no longer be allowed to sell their medical products in the European Union. This legislation change have a big influence on European businesses. In order to find all gaps within a company a complete gap analysis is required. This is exactly where my Excel based gap analysis tool will be of great support and will find all gaps immediately.

Now

Step1

Gap Analysis

2017 May – 2020

Step2

Implementation, Verification

Deadline: May 2020

Step3

Receive of the MDR certificate

Tool Description

The goal of MDR Tool is, to developing digital products which helping Medical Company like Manufacturer, Distributor, Importer, Authorised Representative or Consultants to implement the new Regulation MDR and IVDR in an easy way.

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.

Download

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.

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...

MDR Gap-Tool FULL VERSION (English)

This Excel version includes the complete medical device regulation (EU 2017/745, English version of 5 May 2017). Compatible with: Excel version 2010, 2013 and 2016.

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...

MDR Gap-Tool FREE VERSION (German)

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

Click here

MDR Gap-Tool free Version (German)

Datenschutz: Sollten Sie sich nicht für unseren News Letter entscheiden, werden wir Ihre Daten nach den neuen DSGVO Vorschriften entsprechend löschen.

Sie erhalten wichtige Infos zu MDR, ISO 13485:2016, MDSAP und unseren Tools. News Letter wird maximal 2-mal pro Monat gesendet.

Please wait...

MDR Gap-Tool FULL VERSION (German)

This Excel version includes the complete medical device regulation (EU 2017/745, German version of 5 May 2017). Compatible with: Excel version 2010, 2013 and 2016.

Click here

MDR Gap-Tool free Version (German)

Datenschutz: Sollten Sie sich nicht für unseren News Letter entscheiden, werden wir Ihre Daten nach den neuen DSGVO Vorschriften entsprechend löschen.

Sie erhalten wichtige Infos zu MDR, ISO 13485:2016, MDSAP und unseren Tools. News Letter wird maximal 2-mal pro Monat gesendet.

Please wait...

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 5 May 2017). Compatible with: Excel version 2010, 2013 & 2016

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 FREE VERSION (German)

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 (German)

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 (German)

This Excel version includes the complete IVDR (EU 2017/746, English version of 5 May 2017). Compatible with: Excel version 2010, 2013 & 2016

Click here

IVDR Gap-Tool Free Version (German)

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...

Additional Downloads:

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

Buy now
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

Buy now

Service

QUNIQUE 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
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:

  • Complete GAP-Analysis – In a report format
  • Guaranteed delivery in accordance with defined deadlines
  • Fix Price– No hidden costs
  • Project plan for Implementation
  • The GAP Analysis Tool

How it works:

  • Contact us directly and we will send you a questionnaire
  • Fill out the questionnaire and send it back to us
  • We will send you an offer within 48 hours

Contact us

Feel free to contact us

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MDR STARTING AND SUPPORT PACKAGE:

For more information: CLICK HERE

Your advantages:

  • Access to several MDR tools (see below)
  • Individual Tool instruction (via Webex or Skype)
  • Individual assessment plan (Based on your products)
  • 5 hours starting support with tips and tricks
  • Inclusive our Regulatory Intelligence Paper (for 1 year)

Helpful Links and News

EUR-Lex:

Donwload EU 2017/745 (all languages)

Update: May 17th, 2017

Award:

   

Update: May 30th, 2019: MDR Implementation Guide

For more information CLICK HERE!!!

MDR Implementation Guide

 

FAQ

  • What is the first step after downloading?

    First, go to page “dropdown” in the Excel tool and fill in the following three columns with your own information: Process, Department, Responsibility (the blue text is just an example and should be deleted).
  • What are the MDR ID and IVDR ID columns?

    These are unique ID numbers.

Our Customers