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
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.
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
Commercialization
Consulting and implementation of individually designed sales and marketing strategies, as well as the establishment of a European distributor network or own distribution
Quinn Healthcare GmbH
Reichenstein 24
53804 Much
info@quinnhealthcare.de
Tel.: +49 2245 911 8843 oder
+49 2245 611 9572
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