Medical Devices

From Complexity To Clarity: Decoding Medical Device Regulatory Intelligence And Medical Device Regulatory Compliance

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 medical device regulatory requirements, medical device regulatory information, medical device registration, safety evaluations and QMS. To decode the regulations and device a suitable medical device regulatory strategy, Freyr offers the best of both worlds – a fully configurable software solution with a suite of regulatory intelligence solutions and services that offers best in class, cost-effective and customizable solutions built around your unique requirements covering medical device regulatory compliance across your medical device 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 medical device regulations across drug-device combinations, in-vitro diagnostics, digital health products and more, we help startups and developed companies achieve medical device regulatory compliance by medical device regulatory information updates hence, navigate the ever-changing world complex regulatory landscape.