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Medical Device Risk Management Workshop
Risk management is a critical element of the life-cycle of any medical device that spans from concept of design to postmarket surveillance. Regulators expect that risk management be inherently built into the Quality Management System (QMS) of medical device companies by using the life-cycle approach to implement risk management tools according to Standard ISO 14971:2019 other relevant standards/guidelines like
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Issues to be covered
- Key risk management terms & definitions
- Overview of ISO 14971
- Risk management requirements in ISO 13485:2016
- Using risk management as a tool during design & development
- Applying a “risk-based approach” to all QMS processes
Who should attend
- Managers and personnel of medical device companies involved in regulatory affairs, quality management, R&D, manufacturing, service, marketing
- Team members from medical device startups
Benefits to the Participants
This risk management workshop is designed to help participants understand
• The importance and purpose of ISO 14971
• Identify links between ISO 13485:2016 and ISO 14971
• Evaluate the need to follow other relevant standards/guidelines that apply to the device(s) under their responsibility
• It will also demonstrate how risk management applies to the product life-cycle and how to effectively implement the objectives of a risk management process
By using interactive hands-on workshop and group discussion, participants may develop the knowledge and skills necessary to understand the risk management process and the risk management steps.
About The Lecturer
