Risk Acceptability Safe Enough for Society Frank O’Brien, 30 April 2015 O’Brien Compliance Management Long Island Section Your medical device specialists 1 Frank O'Brien ● Founded consulting firm in 2004 ● Has evaluated 1000's of medical devices; 24 years at UL ● Participates on IEC TC62 committees ● Lives in Boston; in past, San Jose, Frankfurt Germany, Long Island ● BS EE Clarkson College; MS Tech Mgt SUNY Stony Brook. O’Brien Compliance Management ● Medical device safety consulting and testing ● IEC 60601 Training ○ Chicago, Boston ● Free guidance on website, obcompman.com OBCM Office, Chelmsford, MA 3 The goal? ● Calibrate to society’s risk evaluation meter ○ Meaning behind risk management terms ○ Regulatory perspective on risk management 4 Risk Acceptability, Agenda 5 1. Risk Management Quick Review 6 The requirements ● ISO 14971:2007 ○ EN/ISO 14971:2012, Annex ZA ■ key emphasis, reduce risk as far as possible (AFAP) ● Your company’s own Risk Management Procedure, which must implement ○ these RM requirements and ○ any other management policy and objectives 7 Cause, Risk Control, No Harmful Effect Hazard Pre-Risk Post-Risk Harm l o r t n o C k s i R 8 Management process Procedures Records Management Tasks, Risk Management 3.2, 3.3 Plan 3.4 Risk Management Risk Management File 3.5 Tasks, 4 to 9 9 Hypothetical risk acceptability policy ● Reduce risk “as far as possible” (AFAP), based upon ○ Applicable national or regional regulations ○ Relevant International Standards, and ○ Available information such as ■ The generally accepted state of the art (GASOTA), and ■ Known stakeholder concerns ● Periodically review AFAP is dependent on Regulations, Standards and GASOTA, which take into account economic, technical improvements, constraints. In the context of AFAP, “possible”, “feasible” and/or “practicable” have same meaning. ISO 14971, 3.2, and EU MDD, ER 2 10