ISO 13485:2016 – Introduction and Fundamentals
Audience: Introductory, Quality Assurance, Design and Production
Price: Please enquire.
This course covers:
– Introduction to Quality Management Systems (QMS)
– Introduction to ISO 13485:2016
– Fundamental requirements of ISO 13485:2016
– Regulatory oversight on Medical Devices
– Awareness of regulatory requirements of Australia
– Obligations of medical device companies for Quality Management
– Basics of Documents and Record Control
– Other standards relevant to Medical Devices
Participants attend the course in-person over 2 days, this will include scheduled breaks. AuditAct provides refreshments.