Our new eQMS service provider partner, greenlight.guru, recently published a guide on risk management for medical device companies. The guide establishes seven stages that are essential to the risk management process: risk management planning, risk analysis, risk evaluation, risk controls, overall residual risk acceptability, risk management report, and production & post-production information. The guide also includes a list of keywords and definitions that must be understood in order to ensure successful risk management.
Creating a risk management process will allow medical device companies to identify hazards, estimate and evaluate risk, and develop, implement and monitor the effectiveness of risk control measure.
While all findings used to be recorded on paper, this can now be done technologically with the help of greenlight.guru. For more information, read the Definitive Guide to ISO 14971 Risk Management for Medical Devices, or visit greenlight.guru’s website.