Day

March 25, 2014
In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...
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In a new draft guidance (for electrosurgical devices but in our opinion representative of information needed for other devices) FDA stated that cybersecuirty information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...
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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