The FDA now recognizes international standards which may be used to support CE Marking, The CRO Group now offers  a combined software compliance support service. We are conversant in the latest languages including Visual C++ , C#, and Visual Basic, as well as development platforms, as well as the vintage languages.


510K Support

There are now three methods of supplementing your 510k submission when software is involved:

Reviewers Guidance Documentation

IEC 62304 Documentation

ISO 12207 Documentation

CE Mark Support

Two of the FDA recognized international standards are also recognized by Notified Bodies for technical files and design dossiers.

The CRO Group can provide support for your FDA product submission involving software by evaluating the software and preparing documentation to address Reviewers Guidance, IEC 62304 or ISO 12207 requirements, usually by email exchange. Interested? Contact us by clicking here to find out more..