The transition from the IVDD to IVDR regulation is key in the development of your IVD or MD tool. 

All our services are oriented to ensure a high-quality service approach, to show the clinical benefit of your IVD or MD tool and respect the IVDR regulation to ensure a smooth route to market. 

The move from IVDD to IVDR is highly nuanced, and device manufacturers pay a high price for non-compliance. The notified bodies and other partners provide expert support during this transition. Expert oversight by partnering with a third party knowledgeable in IVDR helps IVD manufacturers move toward successful registration and certification with confidence. 

To ensure a proper compliance with the IVDR and FDA regulation, we have high quality services which are all ISO 9001 certified, and all our operations follow the CLSI guideline.