Services for IVD Devices

We support your IVD device's success throughout the regulatory journey.  conducting clinical performance studies, performance evaluations, or developing a clinical development strategy for your in vitro diagnostic

Our services related to IVD regulatory requirements

Navigating the complex, changing regulation can feel like a maze. We create clarity with specialized consulting services. 

• IVD regulatory consulting services 
• IVD performance evaluation
• Clinical performance evaluation
• Conformity assessment for IVDs
• IVD validation and verification regulatory compliance
• Classification and regulation consulting
• Global IVD registrations
  
• IVD post-market surveillance regulatory compliance
• IVD compliance documentation
• In-house IVD device compliance
• Medical writing

Pre-CE clinical performance studies

The purpose of clinical performance studies is to establish or confirm aspects of in vitro diagnostic device performance that cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. The data from clinical performance studies are used in the performance evaluation to demonstrate compliance with the relevant safety and performance requirements with respect to the clinical performance of the in vitro diagnostic.

We provide flexible services 

Our expertise makes your workload lighter. Fast-approaching deadlines are all too familiar to anyone responsible for an IVD device. Our team of experienced Quality Assurance and Regulatory Affairs (QARA) experts helps you create documentation for new devices or update it for legacy in vitro diagnostic devices. 

We provide

• Hourly based services
• Fixed-price services
• Fully outsourced quality managers

We work with different classes and types of IVDs

• IVD categories I, II, III and IV / A, B, C and D 
• Genetic testing

Global IVD Registrations

For bringing a new IVD device successfully to the market, a good product is not enough – it must be also compliant with the applied regulation. We know IVD compliance: So far we have registered medical devices in over 60 countries.