Medical Devices

From Complexity to Clarity: Decoding Medical Devices

Whether it is high or low risk, digital or physical devices, pure-play or combination medical devices- regulatory authorities have strict regulations for all to ensure its safety and efficacy. This demands for careful attention by the medical device manufacturers to the regulatory requirements, safety evaluations and QMS. To decode the regulations, Freyr offers the best of both worlds – a fully configurable software solution and a suite of services that offers best in class, cost-effective and customizable solutions built around your unique requirements covering compliance across the product lifecycle.

We provide intelligence that helps you with medical device classifications, labelling, registrations, approvals, and post-market surveillance. You get access to 5000+ insights categorized into risk classes & product types. With an extensive coverage of global regulations across drug-device combinations, in-vitro diagnostics, digital health products and more, we help startups and developed companies achieve regulatory compliance by helping them navigate the ever-changing complex regulatory landscape.