Day

February 6, 2015
HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...
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The Federal Advisory Committee calendar of meetings is at the link provided. Attendance or downloading of material for most of these meetings is open to the public.
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FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent...
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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.

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

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.