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Risk Management and Usability Engineering for SaMD 

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SaMD Lesson series
  • Level: Basic
  • Study time: 45 Min
  • Exams: Yes
Learning Objectives
By completing this module, you will be able to:
  • Apply risk management principles to medical device software in accordance with ISO 14971:2019 by performing risk analysis and developing appropriate risk mitigations.
  • Conduct usability engineering activities in compliance with IEC 62366-1:2015 +A1:2020.
  • Integrate risk management and usability engineering activities throughout the software development lifecycle.
  • Interpret and apply the latest guidance and standards on risk management and usability from the USA, EU and other IMDRF countries.
  • Document risk management and usability engineering activities in compliance with regulatory requirements.
Course Structure
This module consists of the following lessons:
  • Introduction to Risk Management for SaMD (ISO 14971:2019)
  • Hazard Identification and Analysis
  • Risk Evaluation and Control
  • Residual Risk and Risk Management Review
  • Introduction to Usability Engineering for SaMD (IEC 62366-1:2015 + A1:2020)
  • User Analysis and Use Specification
  • Iterative Design and Prototyping
  • Summative Usability Evaluation
  • Usability Risk Assessment and Mitigation
  • Documentation for Risk Management and Usability Engineering
  • Regulatory Requirements and Guidance
  • Module quiz
Course overview
Course Title:  Risk Management and Usability Engineering for SaMD
Duration: 45 Minutes
Course Type: Self-paced
Modules in Series: 4 of 8

Course Description: Welcome to the fourth module in our eight-part eLearning series on Software as a medical device. Each module is designed so that it can be consumed on its own or as part of the full series. 

This module is designed to provide learners with a practical understanding of risk management and usability engineering for Software as a Medical Device (SaMD). It covers key standards and guidance documents including ISO 14971:2019 and IEC 62366-1:2015 + A1:2020, while exploring the role of bias and health equity in the development of safe, effective and user-friendly medical device software. Learners will gain insight into integrating risk management and usability principles throughout the software development lifecycle to support regulatory compliance and improved user outcomes.

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Introduction to SaMD and Global Regulations

Welcome to the fourth module in our eight-part eLearning series on Software as a medical device. Each module is designed so that it can be consumed on its own or as part of the full series.

This module is designed to provide learners with a practical understanding of risk management and usability engineering for Software as a Medical Device (SaMD).

It covers key standards and guidance documents including ISO 14971:2019 and IEC 62366-1:2015 + A1:2020, while exploring the role of bias and health equity in the development of safe, effective and user-friendly medical device software.

Learners will gain insight into integrating risk management and usability principles throughout the software development lifecycle to support regulatory compliance and improved user outcomes.

What's included?

  • Your own learning portal
  • Self paced module 
  • Certificate of completion
  • Access to a community

Learn with a community

Social learning is a powerful tool that enables individuals to learn from each other through observation, communication, and collaboration.

Using our community, people can more efficiently acquire new knowledge, skills, and behaviors.

Assessments 

Assessments and feedback are essential components of the learning process, offering valuable insights into progress.

All of our courses use knowledge checks throughout to reinforce understanding. 
Learning Objectives

By completing this module, you will be able to:
  • Define the purpose of Process Validation
  • Define what the benefits of Process Validation are
  • Describe the main stages of the Process Validation life cycle


Course Structure
This module consists of the following lessons:
  • What is Process Validation?
  • Definition and fundamental purpose
  • Regulatory expectations
  • Common misconceptions
  • Key Terminology in Process Validation
  • Verification, Qualification, and Validation
  • The importance of documented evidence
  • Process Validation Life Cycle
  • The six stages of validation
  • Real-world case study on process failure
  • Module Quiz
  • Knowledge check to reinforce learning

Created by

Chris Farrance

With over 15 years of experience in regulatory and quality roles, Chris Farrance brings a practical and insightful approach to SaMD development. He has spent the last 6 years working at Google in Regulatory Affairs and previously led regulatory and quality teams across many GxPs. Chris has a knack for translating complex regulatory requirements into clear, actionable steps, drawing on his extensive experience with many standards including ISO 13485, IEC 62304 and he is passionate about sharing his knowledge to help others develop safe, effective, and compliant SaMD.

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Frequently asked questions (FAQs)

Who should attend this course?

The course is suitable for professionals involved in the development, testing, and commercialization of SaMD, including regulatory professionals, software engineers, designers, Quality Engineers, IT support, R&D engineers, and clinicians.

What is Micro Learning?

Microlearning is an approach to learning that delivers small, focused lessons designed for quick consumption and retention. It includes, quizzes and interactive content to enhance learning effectiveness.

Do you supply in-house eLearning?

Absolutely! This course can be purchased for corporate teams and can be tailored to your specific requirements.  For details contact info@leapcompliance.com

Will I receive a certificate after the course? 

After successful completion of this training, you will receive a digital certificate. This certificate can be used to showcase your Process Validation knowledge to employers and Notified Bodies.