Tag

mdds
FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...
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http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/
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FDA issued a draft guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This draft exercises FDA enforcement discretion to essentially deregulate MDDS and Imaging Storage and Coummincation systems despite their classifcation rules. The guidance is at the link provided and proposes the new policy and provides specific wording changes...
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FDA has created a webpage dedicated to regulation of Medical Device Data Systems. Note that the deadline for registration and listing (including for healthcare institutions that would be considered MDDS manufacturers) is May 18, 2011, and the deadline for reporting adverse events through MedWatch is April 18, 2012.
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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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