Services for IVD Devices

We provide effective solutions to address the regulatory changes and challenges encountered in the in vitro diagnostic device manufacturers and in-house laboratories. With their expertise in regulatory compliance, industry experience and tailored approaches, our team facilitates smooth and practical implementations for IVDs.

Expertise that 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 provides support for creating documentation for new devices or updating it for legacy in vitro diagnostic devices.

Our services related to IVD regulatory requirements

IVD regulatory consulting services
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

We provide flexible services

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.