ISO 14971:2019 Risk Management for Medical Devices

Explore the five cross five matrix and its phi kappa phi matrix, combining probability and severity to assess risk levels and guide mitigation.

Set the risk management policy scope and philosophy by management. Document risk acceptability criteria based on probability, severity, clinical history, and expert input, and apply risk-benefit analysis for residual risk.

Explore risk mitigation key points and compare risk estimation before and after risk control using a five cross five matrix, with examples showing low, medium, and high risk outcomes.

Explore the risk management process for medical devices, including risk analysis from intended use and misuse, hazard identification, risk estimation, risk control, and periodic reviews.

Develop risk management plan with hazard identification across concept to post production stages, assign risk IDs and acceptance criteria, and conduct periodic reviews with cross-functional teams and early clinical input.

Identify failure modes and their effects with FMEA, a systematic proactive method for evaluating designs and processes. Learn major types, including system, design, user interface, process, transport and supplier FMEA.

Discover how the risk priority number (RPN) is calculated as the product of severity, occurrence, and detectability, and how thresholds guide actions to minimize risk in FMEA.

Explore case study fmea examples for medical devices, including design fmea on syringe-needle connections and color-coded needle sizes, with ISO 80369 prevention and detection controls to reduce patient harm.

Explore the hazard types in medical devices, including design related, process and manufacturing, user, labeling and packaging, biocompatible hazards, clinical, environmental, and installation hazards, plus fault and normal condition classifications.

Identify hazards and apply fault tree analysis to trace top fault abnormal conditions to root causes, linking damaged devices, manufacturing mistakes, and user errors to patient harm.

Explore ISO 24971 guidelines for hazard identification in medical devices, using a 40+ question framework and product-specific standards like IEC 60601 to address mechanical, electrical, and electromagnetic hazards.

Analyze risk-benefit for medical devices by weighing predicate device data (mod database, PubMed, PMS, evaluation) against clinical investigations for novel devices, then justify benefit with infection risk and risk controls.

Learn risk estimation and risk management reporting by analyzing hazards, probabilities, and severities, applying DPI (design, protective measures, information for safety) to achieve acceptable post-mitigation risk.

Plan periodic reviews of the risk management file from early development to pilot, during testing and validation, and after launch to update risks based on feedback and complaints.

Understand what's new in ISO 14971:2019 versus 2012, including annexure changes, mappings to ISO 24971, new definitions, and revised scope for software as a medical device and residual risk criteria.

Explore ISO 24971 risk management for IVD medical devices, covering hazard identification with annex E, risk acceptability with annex C, and P1/P2 definitions for hazard and harm probabilities.

Identify key risk management documents: probability estimation, risk management plan, hazard list, and risk chart. Maintain them in a separate VHF per organization, and include fault analysis and risk-benefit analyses.