Day

October 23, 2004
While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the...
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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.

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