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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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