Study Management

In order for an In-vitro-Diagnostic product to be placed on the market or put into service, the safety and performance requirements relevant to the product must be met. To demonstrate compliance with these requirements, a performance evaluation must be performed, among other things. The regulations of the new IVDR must be considered and fulfilled. These regulations place high demands on the performance evaluation.

Such a performance evaluation is divided into three essential parts:


Scientific validity


Analytical performance


Clinical performance

Quinn Healthcare can assist you with the complete performance evaluation, or just with individual parts of it. Our services include:

  • A performance evaluation plan and report

  • An analytical performance report based on analytical performance studies

  • A clinical performance report based on literature research, clinical performance studies, or routine use data

Get in touch now

Do you have questions about one of our services, or would you like to explain your project in a personal meeting? Then feel free to contact us directly here.

Our Services


Performance Studies for IVDR

Holistic support for validation, performance testing and documentation of your In-vitro-Diagnostic devices according to the new IVDR


Regulatory Services

Full support in regulatory processes and review of European directives and regulations for In-vitro-Diagnostics and Medical Devices


Supply Chain & Distribution Management

Offer of broad services in the area of logistics, warehousing and distribution of your products



Consulting and implementation of individually designed sales and marketing strategies, as well as the establishment of a European distributor network or own distribution