Quality Training

Software as a Medical Device (SaMD)

This comprehensive 2-day course delivers a practical, hands-on introduction to the regulatory and technical foundations of medical device software development. Centred around IEC 62304, and enriched by related standards such as ISO 14971, IEC 60601, IEC 62366, and IEC 82304, the course walks participants through the complete V-model development lifecycle.

The 2-day course is based on an introductory IEC 62304 programme but goes beyond the basics by incorporating more detailed content on related areas such as usability engineering, risk management, and cybersecurity. While it is designed to be accessible for those new to IEC 62304, it is also highly beneficial for more experienced participants. This is because the course is tailored to the needs of attendees—prior to the training, participants complete a questionnaire that helps the trainer understand their background, experience level, and areas of interest. This allows adaption of the delivery and emphasis of the course accordingly.

From initial requirements management to final validation, we combine industry best practices, real-world examples, and team-based exercises to reinforce understanding and ensure applicability in day-to-day engineering roles. Whether you're new to medical device software or seeking to deepen your regulatory knowledge, this course will provide essential tools, insights, and frameworks to support safe, compliant, and effective product development.

Content includes

Day 1: Core Standards, Development, and Verification

• IEC 62304 Basics and Beyond
  Definitions and terminology
  Evolution and future direction of the standard
  Cross-links to related standards (ISO 14971, IEC 60601, ISO 13485, etc.)
• Global Regulatory Landscape
  MDR/IVDR and FDA classification (SaMD/SiMD)
  Documentation, clinical evaluation, labelling, and roles
  EU and US conformity assessments
• Quality Management Systems
  ISO 13485 and 21 CFR 820
  MDSAP overview
  Continuous improvement, CAPA, KPIs, and audits
• Software Safety Classification
  Determining software safety classes
  FDA documentation levels
• Software Development Lifecycle
  Planning and design controls
  Requirement gathering (user to software level)
  Architecture and detailed design
• Verification Activities
  Static analysis and code reviews
  Unit, integration, and system testing
  Documentation and tools for verification
• Software Release
  Release processes and documentation

Day 2: Maintenance, Risk, and Advanced Topics

• Agile in Medical Devices
  Agile methodologies within IEC 62304
  AAMI TIR45 considerations
• Software Maintenance
  Tool qualification and change management
  Incident handling and feedback loops
• Risk Management (ISO 14971)
  Risk file creation and risk assessment methods (FMEA, HAZOP, STPA, etc.)
  Risk controls and Post-Market Surveillance (ISO TR 20416)
• Usability Engineering (IEC 62366)
  Human factors, usability files, and evaluation methods
  Real-world examples of use errors
• Configuration Management
  Version, build, and release management
  SOUPs and change documentation
• Problem Resolution & Legacy Software
  FSCA/FSN processing
  Handling and documenting legacy software
• Cybersecurity
  AAMI TIR57 and IEC 81001-5-1
  Threat modeling, SBOM, data protection, CVSS, and FDA guidance
• IEC 82304
  Standalone software requirements
  Software discomposure and extended validation

Learning Outcomes
By the end of this course, participants will:

• Understand the full software lifecycle as defined in IEC 62304 and its integration with other key standards
• Apply practical tools and methodologies for risk management, usability engineering, and cybersecurity
• Develop and manage documentation and processes aligned with regulatory expectations (EU, US)
• Gain insights into agile software development, legacy systems, and cybersecurity within the regulated space
• Be prepared to contribute effectively to quality assurance, compliance, and product development teams

Who should attend

Product Safety and Compliance Engineers

Regulatory Affairs and Quality Assurance Professionals

Software and Product Designers

Production Support Engineers

Any team members involved in the development, validation, or regulatory submission of medical device software

Upcoming dates:

Location

Dates

Online, Online

8, 9 July 2025

Book now