This two-hour course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information on Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.
By the end of this medical device ISO 13485 QMS course you will be able to:
This course is vital for any medical device quality professional including quality directors, manager, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485.
By completing/passing this course, you will attain the Medical Device Certificate.