Join internationally esteemed industry experts Audrey Prosser and Rebecca Waterbury as they discuss the key changes to ISO 14971.
ISO14971 Risk Management for Medical Devices
Learn about practical approaches for implementation of the new standard for both new products and legacy products. Hear insights from other companies implementing the revised standard. Learn about global timelines and best practices.
ISO 14971 assists manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this standard are applicable to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device; such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described can also be applied to products that are not necessarily medical devices. Join us Thursday to learn more!
Reference: ISO14971:2019 Medical Devices – Application of Risk Management to Medical Devices
