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AAMI TIR45 / AAMI TIR97 / AAMI TIR57 - AGILE Practices and Risk Management Medical Device Package
AAMI TIR45 / AAMI TIR97 / AAMI TIR57 - AGILE Practices and Risk Management Medical Device Package
AAMI TIR45 / AAMI TIR97 / AAMI TIR57 - AGILE Practices and Risk Management Medical Device Package provides recommendations for complying with international standards and U.S. Food and Drug Administration (FDA) guidance documents when using agile practices to develop medical device software. It also includes guidance on methods to perform information security risk management for a medical device as well as post market risk management.
AAMI TIR45 / AAMI TIR97 / AAMI TIR57 - AGILE Practices and Risk Management Medical Device Package includes:
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
