Quinn Healthcare assist manufacturers with their regulatory processes. They clarify the numerous requirements of European directives and regulations for in vitro diagnostics and medical devices, propose practical solutions to meet them, and/or prepare your technical documentation and design dossiers. We also consider your international orientation outside Europe.
Among other things, we offer assistance with:
Selection process of a Notified Body
Support with IVD directives and IVD regulations
CE approval process
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.
Support in the complete performance evaluation of your product in the field of In-vitro-Diagnostics according to the new IVDR regulations.
Performance Studies for IVDR
Holistic support for validation, performance testing and documentation of your In-vitro-Diagnostic devices according to the new IVDR
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