Beginner (No knowledge at all of the topic).
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.
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