Tag

postmarket
17
May

FDA Final Postmarket Surveillance Guidance

May 17, 2016
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141.pdf
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18
Jun

Reprint of BIT Journal Software CAPA Article

June 18, 2004
The pdf at the link provided is a reprint of an article entitled “Understanding CAPA Requirements in a Software Context” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal published in the Spring of 2004. AAMI – AKusinitz CAPA – article 0504
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Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

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Tampa, FL 33624
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office@softwarecpr.com
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