Module 14 2022

01/04/2022

Recent FDA guidances

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 IEC 62304: 2006 – Medical device software; software life cycle processes  IEC/TR 80002-1: 2009 / -2: 2017 - Medical device software Part 1: Guidance on the application of ISO 14971 to medical device software (includes aspects relevant to ISO14971) Part 2: Validation of software for medical device quality systems  Felten P, Software Testing Basics, 2017  Wiklund M, et al, Medical Device Use Error – Root Cause Analysis, CRC press, 2016.  FDA https://www.fda.gov/medical-devices/digital-health/software- medical-device-samd  Background on Machine Learning https://www.3blue1brown.com/neural-networks Further suggested reading

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