FDA CBER 1994 BECS Manufacturer Letter

This letter was issued at the point FDA ramped up regulation of Blood Establishment Computer Systems as medical devices. It informs manufacturers of such system that they need to comply with all medical device manufacturer regulations and provide premarket submissions for 510(k) clearance of such devices. The letter defines the types of functionality that would be considered as a medical device.

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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