Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)
Hi,
using HACCP as the tool for med device risk assessment; i gather that documentation would include as follows : (based on ISO 14971 requirements)Risk Management Plan: contains the scope; description of the med device and its intended use with characteristics identified; responsibilities and authorities (pertaining risk management process); criteria for risk acceptability, including activities (and results of such) as: hazard id and analysis, risk analysis/assessment including risk estimation, risk control analysis, risk control options analysis; while the rest could be part of the Risk Management Report - implementation of risk control measures, residual risk evaluation; both risk management plan and report are included in the risk management file