DUBLIN, Nov 1, 2018 /PRNewswire/ —
The “Risk Management System in Medical Devices Industry” conference has been added to ResearchAndMarkets.com’s offering.
Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.
Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.
By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers’ guidance.
Upon completing this course participants should:
- Understand the risk management process, the activities, and deliverables as well as the organization framework necessary
- Be able to Interpret and discuss the requirements of ISO 14971
- Develop a risk analysis framework document
- Be able to conduct risk analysis team meetings
- Recognize how and where to use the…