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...Read More
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John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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