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SoftwareGeneral - Support for 510(k)s One of the CRO Group's partners was a member of the HIMA committee which worked with the FDA to revise the original "Reviewers Guidance for Computer Controlled Devices." We have made significant improvements since that first document, both in our understanding of what is needed and at what cost to ensure safe, reliable software. As the FDA now recognizes international standards which may be used to support CE Marking, The CRO Group can now offer you a combined software compliance support service at affordable rates. We are conversant in the latest languages including Visual C++ and Visual Basic, as well as the vintage languages. 510K Support - There are now three methods of supplementing your 510k submission when software is involved:
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, EN/IEC60601-1-4 or ISO 12207 requirements, usually by email
exchange. Interested? Contact us by clicking here
to find out more..
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