Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.
ISO 14971 defines risk management as: “The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.” To that end, a Risk Management Plan is established at a project outset to document how risks are identified, evaluated and traced. This plan should define the entire scope of the risk management process, including the purpose of the device, its life cycle, responsible parties and authorities, and data collection and analysis all the way through post-production.
We worked with Key Tech to create this e-book on de-risking in the MedTech industry.
Table of Contents
- Risk Management Plans & ISO 14971
- De-Risking: Developmental Stage
- Reducing Risk: New Product Development
- The 3 Key Strategies to Evading Risk
- Key Tech’s 8-Point Assessment Checklist
Click through to access the full e-book here.
