Are you ready for the new
medical device regulation?
two partners … one solution


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 analysis report for you that demonstrates the gaps you have with respect to 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


MDR Tool  
MDR including GAP Analyse Service  
MDR – ISO 13485:2016 Tool GAP Analysis Service  
MDR – MDSAP – ISO 13485:2016 Tool including GAP Analysis Service

The MDR Gap-Analysis Tool includes the complete medical device regulation. The main focus of this tool is to find all gaps taking both the patients as well as the businesses risks into consideration. Furthermore, the tool will allow you to sort by table of content, articles, processes, risks, priorities, department or even responsibilities. All these different options will ensure a smooth implementation of the new medical device regulation into your company. Tool Description:

Download free Demo Version

 English            Deutsch 

  • Significant saving of working hours
  • Complete medical device regulation (May 5th, EU 2017/745)
  • Simple and fast evaluation of gaps
  • Easy allocation of responsibilities (across all departments and responsible persons)
  • Risk assessment (patient and business)
  • Prioritization of each gap
  • Search-Function


This Excelversio includes the complete meical device regulation (EU 2017/745
versionof 5th may. Compatible with: Excel verson 2010, 2013 and 2016
NEW: Inclusive “Checkliste Classification Rules” work paper !!!





About us

Our Vision: We offer medical device manufacturers the opportunity to prepare for new or existing challenges in the quality or regulatory environment in structured and efficient way. For our services we use self developed and validated tools that allow a timely, complete and reliable GAP anlysis and combine it with a GAP report and project plan. We revolutionize the switch from evaluation and planning to implementation through simplicity, transparency and efficiency.


coming soon