Medical Device Compliance Tools

Explore our list of tools designed to simplify medical device regulatory compliance. Whether you're dealing with MDR, IVD, or FDA regulations, our resources provide the answers you need to ensure your products meet all legal requirements

MDR Classification Determination

Determine the classification of your medical device under the Medical Device Regulation (MDR) with our intuitive tool and get a free fully compliant classification document for your technical documentation.

SOUP License Checker

Need to build your Software of Unknown Provenance (SOUP) list and struggle to gather all the licenses for the dozens of dependencies across your services?
Fear no more, this tool will save you the next couple of hours.

IVDR or MDR Checker

Quickly figure out if your software as a medical device is governed under In Vitro Diagnostic Medical Device Regulation (IVDR) or Medical Device Regulation (MDR).