In Vitro Diagnostics
Is your IVD getting re-classified under the new classification rules?
Are you ready for the extended requirements to your Analytical Performance Report and your Post Market Performance Follow-up? We can help your company transition to the new IVDR.
Chemical and Analytical Support
Have you gathered sufficient clinical evidence for the performance of your IVD? We can assist you in writing or updating your Analytical Performance Report and your Performance Evaluation Report.
We can help you establish an excellent system for your Post Market Surveillance and write your Post Market Follow-up plan according to regulatory expectations.