BSI and ISO/TC 210 jointly organize a workshop on risk management for medical devices. The main reason for this workshop is the imminent publication of the revised edition of ISO 14971 (“Medical devices - Application of risk management to medical devices”) and ISO/TR 24971, its companion document.
BSI and ISO/TC 210 jointly organize a workshop on risk management for medical devices. The main reason for this workshop is the imminent publication of the revised edition of ISO 14971 (“Medical devices - Application of risk management to medical devices”) and ISO/TR 24971, its companion document.
Location: BMA House Conference & Events Venue (Tavistock Square, Bloomsbury, London WC1H 9JP)
Date & time: Tuesday 8 October 2019 13:30 – 17:00 hrs
Open to: participants in the ISO/TC 210 meetings as well as others interested in the subject matter
Participation fee: Free, but registration is required and space is limited
The first part of the workshop will provide presentations on the content of the revised ISO 14971, on key terminology for this standard, on alternative terminology related to risk, and on the impact of terminology choice for other medical device standards, like ISO 13485 (Quality Management Systems).
During the second part of the workshop, we will brainstorm on a few selected topics relevant for the risk management process for medical devices and the possible future role of risk management in realizing safer and better medical devices.
Speakers in the workshop include the world’s leading experts in medical device risk management, both from industry and regulatory agencies.