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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Analytical performance
Rely on us to ensure that your IVD tool meets all analytical criteria
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Clinical performance
Make sure that your IVD tool yield results with the right clinical condition
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Post-market surveillance
Guarantee the safety of your IVD tool after the market launch
Discover how to be compliant with the IVDR regulation
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Reach out to our experts and see how we can help advance your research
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