Introduction to ISO 13485:2016

Thursday, Feb 27, 2020, 9:00 am - 5:00 pm

ISO 13485 Course Description:

This course is intended to provide an overview of the ISO 13485:2016 Medical devices -Quality management systems - Requirements for regulatory purposes.

 This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, and final decommissioning and disposal of medical devices.

 This course can be used to formally document training to the ISO 13485 International Standard for internal auditors and external (supplier) auditors.

ISO 13485 Course Topics:

  • Discuss the history of ISO Standards
  • Evaluate the Seven Quality Management Principles
  • Understand the process approach
  • Understand risk-based thinking
  • Identify and discuss common risk management tools
  • Identify and discuss the ISO 13485 clauses including best practices

Register online here. **Registration of three or more participants from one company is discounted to $475.00 per participant**

Instructor: Derrick Mason

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