ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes (2 hrs)

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.

Key learning objectives:

By the end of this medical device ISO 13485 QMS course you will be able to:

• Define the primary purpose of ISO 13485
• Identify the general and documentation requirements of a QMS as outlined in Clause 4
• Recognize the responsibilities of management in a QMS as outlined in Clause 5
• Identify the resources needed to implement and maintain an effective QMS and to meet regulatory and customer requirements as outlined in Clause 6
• Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
• Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8

This course is vital for any medical device.