A Fast and Efficient Path to MDR/IVDR Certification

We have a 100% success rate in helping our clients transition to compliance with new EU regulations for medical devices and in vitro diagnostic devices. Our service typically begins with a gap analysis of the Quality Management System and applicable Technical Files or Design Dossiers.

The output of the gap analysis is generally a detailed action plan for MDR or IVDR compliance for the business and applicable devices.

We can then work with our clients in a few ways. We either take full ownership of the transition and implement the action plan, managing remedial activities, creating an updated QMS for the business and Technical Documentation for each product, including Clinical Evaluation Plans and Clinical Evaluation Reports and Performance Evaluation Reports. Alternatively, we can provide guidance, mentorship and reviews for clients who prefer to undertake most of the remedial activities themselves.

Our experience is broad and covers all classes of devices including implantable devices, complex electro-mechanical systems, software as a medical device, mobile medical apps, in vitro diagnostics devices and Artificial Intelligence and Machine Learning.

For smaller businesses, we can also act as the Person Responsible for Regulatory Compliance (PRRC).