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FDA issued a draft guidance “Radiation Biodosimetry Devices” dated Dec. 30, 2014.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.

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Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

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