FDA Radiation BioDosimetry Device Draft

FDA issued a draft guidance “Radiation Biodosimetry Devices” dated Dec. 30, 2014. This guidance focuses on performance data and algorithm feature selection as well as labeling. Section V.G. idnicates electronic data submisiioon is encouraged but should include the programs used to genereate results should be incliuded in a way that can be easilty transferred into statitistical software. Section C.8 Instrumentation and Software simply references FDA’s general software submissions guidances.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

Corporate Office

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