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Risk Management for Medical Device

Format Virtual

Designed for engineers, technicians, and professionals focusing on product and process risk, this course teaches you the common risk-management methods used in product design and manufacturing processes. It also focuses on recently enacted standards specifically related to medical device risk management. Using case studies and interaction, you will practice identifying and analyzing potential product and process hazards, FMEA, hazard and Fault Tree Analysis, Hazard and Critical Control Point, and all the critical skills needed to create a risk management plan, process, report and file.

This course illustrates commonly used risk-identification and risk-reducing methods. Through examples it shares practical applications implementing tools described by several of the recently enacted or updated standards and technical reports relevant and applicable to medical device risk management, (ISO/EN 14971:2012 with a 2019 update summary (little change in Risk Management process), what will be in the TR/ISO 24971:2013-->2019, risk as related to 21 CFR 820 and as related to ISO 13485:2016, impacts of software risk assessment for IEC 62304:2015, and impacts of risk on human factors engineering IEC 62366-1:2015). Through examples, the instructor explains how to identify and analyze product and process hazards, evaluate the hazards for possible level of risk, and ways to creatively brainstorm on mitigating the risks, both for FMEA's, but also Fault Tree Analysis. Lastly, this course has been taught to many industries, including chemical, toy, aerospace, electronics, and directly to the FDA.

ASQ virtual courses provide electronic access to course materials for 30 days beginning five days before the first day of your course.  Extensions and/or refunds cannot be issued if course materials have been accessed.  Chrome and Edge browsers are recommended – Internet Explorer is not supported. 

Course Data

  • CEU Hours: 0.7
  • Length: 7 Hours
  • ASQ RU: 0.7
  • Audience: Practitioner
  • Provider: ASQ
Course Overview

Learning Objectives:

  • Identify and analyze hazards of product, process, or service.
  • Create a process map.
  • Perform fault tree analyses.
  • Perform failure mode and effects analyses.
  • Perform hazard analysis and critical control points.
  • Understand and analyze software hazards.
  • Understand basics of human factors and its relationship to risk management.
  • Begin performing risk management in your company.



Who Should Attend:

Quality managers, engineers, and technicians involved in the development/manufacture of medical devices. Professionals directly involved in meeting FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the quality system regulation, including direct work experience.

  1. Summaries of risk management processes
    1. Risk management
    2. Fault tree analysis (FTA)
    3. Failure mode and effects analysis (FMEA)
    4. Process mapping
    5. Hazard analysis and critical control point (HACCP)
    6. Human factors
    7. Software safety
  2. Example templates
  3. Summary

Detailed Course Description

Using tools such as critical process point identification/mitigation, the course explains the application of both predictive and preventive processes to the product development cycle, production phases, and field product performance monitoring. It shows how you can adapt these for your specific needs. The instructor will briefly summarize and introduce the issues facing the FDA and Europe early on, which moved them toward the focus of requiring risk management in all aspects of product development and manufacturing, including mechanical, electrical, software, and disposable products. The following tools will be discussed with case studies included to spur class activity in practicing the various hazard and risk analysis and risk management: hazard identification (HA), fault tree analysis (FTA), failure mode and effects analysis (FMEA), and hazards and critical control point analysis (HACCP). Others, such as hazard and operability study (HAZOP), software risk management, and human factors analysis will be briefly reviewed. Example procedures will be provided and discussed.


Virtual, instructor-led, uses WebEx platform


A PDF version of the presentation and relevant handouts will be available to download at the beginning of the session.
System Requirements
Here is what you need to participate in an ASQ web-based, self-paced, or instructor-led virtual WebEx course.

Registration Email

After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.

Technical Requirements

  • Computer – PC or Macintosh
  • High-speed internet connection
  • Adobe Flash Player 10.3 or later
  • Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
  • Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
  • For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)

NOTE: Refer to product description for any additional system requirements.

WebEx – Virtual Course: Advance Preparation and Student Information

Join a Test Session

We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.

If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.

To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."

Deactivate Pop-up Blockers

You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.

Cancellation Policy
ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.
  • If you need to cancel, we will refund your paid registration fee as noted below.
    • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
Barrett Craner CBA, CQA, CQE, CRE

Enrollment Details

Format: Classroom
Format: Virtual

A web-based, live, classroom-like instructor led experience allowing attendees to interact without traveling. Course includes online access to materials for a limited time and up to three hard copy prints. Some courses include an electronic book – see course description for details.

No Offerings Scheduled English List: $899 Member: $699


Employees in training meeting stock photo



ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.

5 Benefits of On-Site Training

  1. Expertise to your location: Saves time and travel expenses
  2. Convenient scheduling: Train groups of five or more
  3. Customizable courses: Training tailored to your groups’ needs
  4. Immediate results: Employees complete courses ready to apply what they’ve learned
  5. Value-add support: Instructors available to answer questions after session