Software as a Medical Device: Essential Concepts Series
Explore our series of self-paced micro topics on Software as a Medical Device (SaMD), designed for flexible learning. Each module covers a specific aspect of SaMD, allowing you to complete them individually or as a comprehensive series. Perfect for busy professionals, these engaging topics provide essential insights into regulatory requirements, development processes, and best practices. Enhance your knowledge at your own pace and build a robust understanding of SaMD.
At a Glance
- Learning Level: Basic
- Total Length of Series: 6 Hours
- RAC Points: 6
- This course was developed by Leap Compliance
Learning Objectives
Upon completion of this course, participants should be able to:
- Interpret the global regulatory landscape for SaMD and determine an appropriate regulatory pathway and compliance strategy for a SaMD product.
- Apply relevant standards and regulatory requirements throughout the SaMD software development lifecycle.
- Develop and document software requirements and design specifications that incorporate risk, usability, and regulatory considerations.
- Integrate risk management, human factors/usability, cybersecurity, and data privacy into SaMD development and lifecycle management.
- Plan, conduct, document, and trace verification and validation activities using a risk-based approach.
- Manage SaMD after release through controlled maintenance, change management, post-market surveillance, and lifecycle documentation.
- Evaluate and address the additional regulatory, data, validation, and change-management considerations associated with AI/ML-enabled SaMD.
- Module 1: Introduction to SaMD and Global Regulations
- Module 2: IEC 62304 - Building Safe and Reliable Medical Device Software
- Module 3 : IEC 62304 - Software Design and Setting Your Requirements
- Module 4 : Risk management and Usability (Human Factors)
- Module 5 : Cyber security and Data Privacy
- Module 6 : Software Testing: Verification and Validation
- Module 7 : SaMD maintenance
- Module 8 : AI/ML SaMD are there extra considerations?
Enrollment Period: 12 months
Industry Expert
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.
