1 Day
These courses will run from 9.30am - 4.30pm (IST/UTC+1).
Instructor - led virtual training.
€365
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
ISO 13485:2016 Quality Management System for Medical Devices is an international standard that defines the requirements of a quality management system for organisations within the medical device industry. This covers processes spanning the entire product life cycle, including design and development, production, warehousing, distribution, installation, and servicing activities.
In this course participants will learn about the fundamentals of ISO 13495:2016. This training will also help participants understand the impact of not adhering to ISO 13485:2016 requirements.
On completion of this training, participants will be able to:
• Understand the ISO 13485:2016 requirements
• Understand the terms and definitions within the standard
• Interpret the clauses of ISO 13485:2016
• Identify QMS documentation requirements
• Communicate the importance of understanding regulatory requirements
• Learn the importance of ISO 13485:2016 to the organisation
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 conducted numerous ISO 13485:2016 audits.
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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