MDCI: Guiding Innovation

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Medical Device Software

MDCI has assisted clients in preparing documentation for a many types of software and firmware components of a wide range of medical devices to ensure FDA compliance and adherence to other international regulatory requirements.

• Picture archiving and communications system (PACS) software
• Image management, processing, and analysis software

Medical Device Software Case Study

A U.S. based software company with no previous experience with the submission of 510(k)s developed a software product for the management, viewing, and processing of DICOM-compliant images. The client was not familiar with FDA requirements for 510(k)s, software documentation, labeling, and development of DICOM conformance statements.

MDCI critically reviewed the company's labeling and software documentation and provided a template and guidance for development of a DICOM conformance statement. MDCI prepared the 510(k) and submitted the 510(k) to FDA along with the modified documentation. The device was cleared in less than five weeks with only one FDA request, which was to change the wording in the Indications for Use.

Contact us for more information about medical device software documentation.