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IVDR & FDA regulation

Cerba Research is committed to providing  a high standard quality service, and guiding you through  the IVDR and FDA validation of your device. 

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. 

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