10/8/2023 0 Comments Iso 13485 fdisRecords…shall be maintained.Note 3: See ISO 14971 for guidance related to risk management.7.3.2 Design and Development Inputse) the Output(s) of risk management (see 7.1).3Copyright 2009 Daniel Brown ![]() ISO 13485 & Risk Analysis7.1 Planning of Product RealizationThe organization shall establish documented requirements for risk management throughout product realization. ISO 13485 & Risk AnalysisISO 14971Why this matters to Medical Device ManufacturersISO 9001 & Risk AnalysisISO 31000What this means for other manufacturersOverview2Copyright 2009 Daniel Brown ![]() ISO 13485 & Risk AnalysisWhy Risk Analysis MattersPresented to ASQ Fox Valley Section 1208October 6, 2009By Daniel Brown, CQA on behalf of Eagle Registrations
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