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Quality systems, business processes and the skills your people need to make it all work.
This course is designed to introduce the ISO 14971:2019 – Risk Management for Medical Devices standard and provide participants with an understanding of the impact that risk management has on their decision-making process. All elements of the standard will be covered, with an emphasis on the role of risk management in the medical device industry and the relationship between ISO 14971 and ISO 13485 Quality Management Systems.
Through a combination of presentation, group discussion, and moderated group activities, participants will gain a working knowledge of the ISO 14971:2019 requirements for medical device risk management, as well as practical experience applying the ISO 14971 risk management process to a medical device.
Through a combination of presentation, discussion and exercises, participants will:
Participants should have experience with, or knowledge of, quality management systems for the medical device industry. A basic awareness of medical devices, quality assurance, and ISO 13485 is recommended.
|Open or Dedicated
Open Enrolment, Dedicated Session
Medical Devices (ISO 13485, ISO 14971)
Mar 4-5, 2024 – 1:15pm to 5:15pm ET
Monday: 9am-5:30pm EST
Tuesday: 9am-5:30pm EST
Wednesday: 9am-5:30pm EST
Thursday: 9am-5:30pm EST
Friday: 9am-5:30pm EST