A new IVD expert with significant experience within the industry has joined our medical device team improving our capabilities to offer quality and regulatory services for IVD companies. We can now offer services complying e.g. with the IVD directive / new IVD regulation and US FDA QSR requirements for a variety of different IVD products and systems. Our services cover the whole product life-cycle.
More information and examples of the services we offer can be found on our webpage for medical devices and IVDs .
Please also remember our services for performance evaluation studies (Clinical study services). Our laboratories can offer microbiological analysis, chemical analysis and stability study services for IVD customers, as well (Analytical services).
Whether you need help on a single assignment or for a complete project, we are here to serve you. For further information, please contact:
Regulatory Affairs Manager, Medical devices
Tel. +358 40 6686 796
Regulatory Affairs Expert, In Vitro Diagnostics
Tel. +358 50 3130 323