2 Days
These courses will run from 9.30am - 4.30pm (IST/UTC+1).
Instructor - led virtual training.
€595
A certificate of completion will be issued on successful course completion.
Beginner (No knowledge at all of the topic).
Each participant will receive a training manual
This two-day course is designed to provide participants with a comprehensive understanding of ISO 14971:2019, the international standard for risk management of medical devices. The course will cover the essential principles, concepts, and requirements of the standard, and provide practical guidance on how to apply them in real-world situations.
ISO 14971:2019, provides the processes for identifying, evaluating, and mitigating hazards associated with the use of medical devices. While not mandatory, it is the most commonly used, industry-recognized standard to demonstrate conformity to when addressing product safety requirements.
On completion of this training, participants will be able to:
The course is designed for professionals working in the medical device industry, including product managers, engineers, quality assurance personnel, regulatory affairs professionals, and others who are involved in the design, development, and manufacturing of medical devices.
The course is also beneficial for individuals who are seeking to enhance their knowledge and understanding of the ISO 14971 standard and its application in the medical device industry.
Dr. Fiona Masterson
With over 25 years’ experience in quality management, operations management, and higher education, Fiona combines technical expertise with highly engaging training. She has worked in fast-paced manufacturing environments including medical device companies, and lectures part-time in universities. She is a lead quality auditor and has extensive experience in auditing risk management systems.
She has Bachelor and Master of Science degrees, and a Doctorate in Mechanical Engineering. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.
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