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Introduction to SaMD and Global Regulations

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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:
  • Understand device classification for SaMD devices according to the FDA and EU regulatory frameworks
  • Identify other regulatory frameworks for the IMDRF countries
  • Understand the different routes to market for SaMD devices
  • Select the appropriate regulatory strategy for a given SaMD device
  • Understand when and why to apply ISO 13485 and Identify gaps in your current compliance systems

Course Structure
This module consists of the following lessons:
  • What is SaMD?
  • Global regulatory landscape of SaMD: Identify and differentiate between regulation, standards, and guidance
  • Regulatory requirements (standards, legislation and guidance)
  • Understanding device classification
  • Mobile Medical Applications
  • Activity: classify your SaMD
  • Regulatory Pathways in the EU and USA
  • Regulatory requirements (standards, legislation and guidance)
  • An introduction to risk including examples of applying IEC 62304 and ISO 14971
  • Activity: Develop a route to market
  • QMS and ISO 13485 for SaMD
  • Module quiz
Course overview
Course Title:  Introduction to SaMD and Global Regulations
Duration: 45 Minutes
Course Type: Self-paced
Modules in Series: 1 of 8

Course Description:Welcome to the first 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 an introduction to and understanding of the regulatory landscape for software as a medical device (SaMD). It will cover topics such as device classification, route to market, and regulatory requirements.

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Introduction to SaMD and Global Regulations

Welcome to the first 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 introductory course is the first module in the series, and it is designed to provide learners with an introduction to and understanding of the regulatory landscape for software as a medical device (SaMD).

By the end of this module, you will have a awareness SaMD regulations and a strong foundation to build upon in subsequent lessons if you choose to.  

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.