The most time consuming item in setting up an electronic Medical Device Report (eMDR) is setting up the “contract” with the FDA. First, you must sign up, create a certificate, and send it. After this, FDA will state you are ready to begin testing. The testing period involves creating all business rules in relation to the creation of the Extensible Markup Language (XML) file or the H07 file to follow FDA requirements. Often times this process involves doing many submissions, receiving failures, and making changes until you receive a positive acknowledgement from the FDA.
The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.