QUNIQUE GmbH and Regulatory Globe offer you a unique Service in the following Packages:
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:
How it works:
|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:
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.