Technical Training

Medical Device Software & IEC 62304

Over 2-days this comprehensive course will give you the fundamental regulatory and technical foundations of medical device software and IEC 62304. Learners will explore the interplay with related standards (such as ISO 14971, IEC 60601, IEC 62366, and IEC 82304) and the essential tools, insights, and frameworks needed to support safe, compliant, and effective product development. From initial requirements management to final validation, our expert trainer combines industry best practices, real-world examples, and team based exercises to reinforce understanding and ensure applicability in your day-to-day roles.

The 2-day course covers the fundamentals of IEC 62304 but goes beyond the basics by incorporating a more detailed look at agile development, usability engineering, risk management, and cybersecurity. The course is customised to the audience so while it is accessible for those new to medical device software and IEC 62304, it is also highly beneficial for more experienced participants who seeking to deepen their understanding.

All participants will complete a pre-course questionnaire that helps the trainer understand their background and experience level. This allows adaption of the delivery and tailoring of each course accordingly.

Content includes

Day 1: Core Standards, Development, and Verification

• IEC 62304 Basics and Beyond
  Definitions and terminology
  Evolution and future direction of the standard
  Interfaces with related standards (ISO 14971, IEC 60601, ISO 13485, ISO TR 80002-1 etc)
• Software in the Context of Global Regulations (MDR/IVDR and FDA)
  Classification of SaMD and SiMD
  Technical documentation, clinical evaluation and investigation,
  Labelling
  Conformity assessment and declaration of conformity
• Quality Management Systems
  ISO 13485 and 21 CFR 820
  MDSAP overview
  Continuous improvement, CAPA, KPIs, and audits
• Software Safety Classification
  Determining software safety classes
  Determining FDA documentation levels
• Software Development
  Software development plan and design controls
  Requirement gathering (user, system and software) and management tools
  Software architecture and detailed design
• Verification Activities
  Static analysis and code reviews
  Unit, integration, and system testing
  required documentation and useful tools
• Software Release
  Software release processes

Day 2: Maintenance, Risk, and Advanced Topics

• Agile in Medical Devices
  Agile methodologies within IEC 62304
  AAMI TIR45 considerations
• Software Maintenance
  Tool qualification and maintenance plans
  Incident handling and feedback loops
  Change management
• Risk Management process (ISO 14971)
  Risk management file and risk assessment methods (FMEA, HAZOP, STPA, etc.)
  Risk controls
  Post-Market Surveillance (ISO TR 20416)
• Usability Engineering (IEC 62366)
  AAMI TIR 51, ANSI AAMI HE75 and other useful resources
  Usability Engineering File
  Human factors, hazards and hazard related use scenarios
  Evaluation methods
  Real-world examples of use errors
• Configuration Management Process
  Version, change build, and release management
  SOUPs
• Problem Resolution & Legacy Software
  Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)
  Requirements on legacy software
• Cybersecurity
  Security considerations according to AAMI TIR57
  IEC 81001-5-1
  FDA cybersecurity guidance
  Threat modelling, SBOM, data protection, risk evaluation and CVSS,
• IEC 82304
  Requirements for stand-alone software, software validation and discomposure.

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

• Understand the full software life cycle 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

All team members involved in the development, validation, or regulatory submission of medical device software (SaMD/SiMD) including;

Product Safety and Compliance Engineers

Regulatory Affairs and Quality Assurance Professionals

Software and Product Designers

Production Support Engineers

Upcoming dates:

Location

Dates

Virtual, Instructor-led, Online

8 - 9 July 2025

Book now