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In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including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In a new draft guidance (for electrosurgical devices but in our opinion representative of information needed for other devices) FDA stated that cybersecuirty information including but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

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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