ISO 14971-Incorporating Risk Management throughout the Product Life-cycle

Duration: 90 Minutes
A key process for all medical device companies is product risk management. While this webinar focuses on the application of risk management to product outlined in ISO 14971:2007, we will also discuss the risk-based approach outlined in ISO 13485:2016.
ISO 14971
Instructor: Mark Swanson
Product ID: 501368
Objectives of the Presentation
  • Understand the general use of the ISO 14971 standard
  • Understand the reasons for the EN ISO 14971 version
  • Understand the application of the risk management to the medical device life-cycle
  • Understand how these changes affect an organization involved in the medical device industry
  • Be able to use the content to implement the required changes in an organization to obtain or maintain a quality certification
  • Determine other considerations for obtaining or maintaining a certification for an ISO 13485 quality system
Why Should you Attend
This webinar is focused on the application of risk management throughout the product life-cycle including: Product design & development, process design & development, design transfer and post-market surveillance and follow up. It is important to understand how risk management files are developed and then maintained throughout the product life-cycle from initial concept through development & delivery to final decommissioning/disposal.

Areas Covered
  • A brief overview of the ISO 14971 standard, and the importance of the EN version of the standard
  • Application of ISO 14971 within product development
  • The use of the risk management file throughout the product life-cycle
  • How to maintain your product risk management files
  • What to do if your risk management files don't exist or hasn't been maintained
  • Other considerations for medical device organizations
Who can Benefit
This will be a webinar that focuses on what design assurance engineers, quality managers, quality system engineers, quality auditors, complaint handling personnel and other personnel involved in product risk management processes will want to know about the ISO 14971 standard and strategies to implement a risk-based approach in other processes within the medical device organization.

Topic Background
The ISO 14971 standard is the sector standard for product risk management within medical device organizations. This standard provides the outline of a process or processes a medical device organization must implement to meet the requirements for the application of product risk management. In addition, attendees will discuss the use of a risk-based approach to other quality system management processes.
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Instructor Profile:
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group, a group focussing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is also the Director of the Medical Technology Quality Graduate program at St. Cloud State University.

Mark has spent the last three years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 and has also participated with ISO TC176, WG24 on the next version of ISO 9001. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate the different management system standards and other regulations into a single quality management system.
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