Medical Device Software Development Process

Gain practical, up‑to‑date expertise in IEC 62304

This course gives software developers in the Medical Device and IVD industry a clear understanding of software lifecycle requirements, safety classification, AI/ML considerations, and integration with risk management standard ISO 14971 – equipping you to develop compliant software and prepare the right documentation for regulatory success.

Course outline

• Introduction
• History of software standards in medical devices.
• Terms & definitions
• General Requirements:
  • Software safety class
  • Changes expected in 2nd edition to be published late 2026
• Software Development Process
  • Development tasks and deliverables
  • Interpretation of the standard for AI/ML software
• Software Risk Management process
  • Interplay of IEC 62304 with ISO 14971 Application of risk management to medical devices
  • Specific tasks and documents required for software
• Configuration Management process
• Problem Resolution process
• Software Maintenance process

Learning objectives

• Knowing the main goals of the IEC 62304 standard.
• Knowing IEC 62304 requirements throughout the lifecycle of software.
• Understanding how IEC 62304 integrates with Risk Management activities.
• Knowing what documents to write to show compliance to the standard.

Who should attend

People working for medical devices or in vitro diagnosis manufacturers:

• Quality Assurance and Regulatory Affairs Managers,
• Software Project Managers,
• Software Development, Risk Management, and Test Engineers

Prerequisites

• You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).

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