March 22, 2016

Mar

$SCPR 62304 Checklist Revised for Amendment 1$

March 22, 2016Alan KusinitzBlog, Prem

The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.

Mar

IEC 62304 Amendment 1 Reminder

March 22, 2016Alan KusinitzNews

Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A...

Mar

FDA Guidance Genetic Tests for Heritable Markers

March 22, 2016Amy SellersNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077862.htm

$SCPR 62304 Checklist Revised for Amendment 1$

IEC 62304 Amendment 1 Reminder

FDA Guidance Genetic Tests for Heritable Markers

Upcoming Public Courses

Corporate Office

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$SCPR 62304 Checklist Revised for Amendment 1$

IEC 62304 Amendment 1 Reminder

FDA Guidance Genetic Tests for Heritable Markers

Upcoming Public Courses

Corporate Office