diagnostics2market

 

 

 

IVD Regulation

 

STRICTER RULES AND OBLIGATIONS

Among other things, you will be required to provide post-market surveillances, a comprehensive QM system, accurate technical documentation, risk management, regulated labelling and a compliance officer. Notified bodies can conduct unannounced audits.

You are probably faced with the choice of either upgrading your in-house laboratory or looking for external laboratory partners. In addition, development times are increasing due to higher requirements for certification studies. And the competition is becoming more complex, for example because new hurdles are increasing for the market entry of fresh ideas.

In order to pave the way for new ideas to be put into practice, we offer our development partnership.