14971 Risk Management Training Course

ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective

Public Training Course DATES:  Jan 9-11, 2023

COST: 3 Full Days for $2,995


3 or more students from same company: 10% discount (off full registration)

Early Bird Registration:  $1,995 (limited quantity)

September and October 2022 Early Registration:  $2,295

Register Now

Come to sunny Tampa, Florida in January 2023 for our newly updated “ISO 14971 Medical Device Risk Management, A Software Organization’s Perspective” 3-day training course.

This course takes a deep dive into ISO 14971:2019 so that people responsible for SaMD can develop and deepen their understanding of the device level, or product level, risk management requirements. We have found over the years that many of our clients struggled with software risk management because they did not fully embrace device level risk management. This course gives the students a full understanding of ISO 14971 and then explains how cybersecurity, usability, and software risk analyses feed into the device level risk analysis. The course follows the typical process (or processes) introduced by ISO 14971 and IEC 62304, and integrates IEC/TR 80002-1 as a valuable resource for software risk management.

Course Modules

  • Regulatory and Standards Background
  • Intended use / harm
  • System Level Hazard Analysis
  • Detailed Risk Analysis Methods
  • Use Error Hazard Analysis
  • Cybersecurity Threat Analysis
  • Software Hazard Analysis
  • Risk Estimation
  • Risk Control
  • Risk Evaluation and Residual Risk
  • Production and Post Market Risk Management
  • Planning & Documentation

Who Should Attend?

  • System Engineering
  • Safety/Risk
  • Cybersecurity
  • Software Engineering
  • Ux
  • Quality Assurance
  • Regulatory Affairs
  • Product Owners
  • Scrum Masters/Coaches
  • Software development management
  • Production/DevOps
  • Test management/engineering


This 3 day course will be taught by Brian Pate of SoftwareCPR and Dr Peter Rech of SoftwareCPR.


Full credentials on our website: www.softwarecpr.com


Training Course Location

Center for Advanced Medical Learning and Simulation

Tampa, Florida USA



About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767


Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


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