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Medical device risk management template
Medical device risk management template










medical device risk management template

A pointer to the PMS plan and procedures will be sufficient. Items 19 and 20 are part of the PMS process.Items 14, 16, 17 can be merged (end generally are) in the Risk Management Review and Report 18.

medical device risk management template

Alternatively, if each mitigation has a corresponding (traceable) requirement, the trace is taken care of by the requirement → verification traces. Item 3 provides links for items 12 and can be built into the risk analysis documents.

medical device risk management template

  • Items 6 and 9 can be built into the Risk Management Plan 2.
  • Items 4, 5, 7, 8, 10, 11, 13, 15 are generally contained in each single risk analysis document.
  • Items 1 and 5 are typically contained in separate documents in the DHF.
  • This seems a lot, but let’s look into the details of these items:
  • (10.4) Decision arising from the review of post-production information.
  • (10.3) Results of the review of the post-production information.
  • (9) Risk Management Report, including Risk Management Review.
  • (8) Evaluation of Overall Residual Risk.
  • (7.6) Review of completeness of risk controls.
  • (7.5) Risks arising from implemented risk control measures.
  • (7.4) the results of the Benefit-Risk Analysis.
  • (7.2) Verification of Implementation of the Risk Control Measures.
  • (5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
  • (5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).
  • Where appropriate, the manufacturer shall define limits of those characteristics.
  • (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device.
  • (5.2) Intended Use and Reasonably Foreseeable Misuse.
  • (4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.
  • medical device risk management template

  • (4.2, Note 3) The policy for establishing criteria for risk acceptability.
  • In practice, the risk management file must contain, or have reference to, the following documents: ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”.












    Medical device risk management template