Technical Training

IEC 62304 and Emerging Standards for Medical Device & HealthIT Software

Objectives

This comprehensive course is designed to equip professionals with a deep understanding of IEC 62304:2015 and other emerging standards governing medical device and HealthIT software development. Participants will gain insight into US regulations, compliance expectations, and industry best practices, ensuring they can navigate audits and regulatory reviews with confidence. Beyond compliance, the course emphasizes the intent and purpose behind these standards, enabling attendees to make informed decisions in their roles.

Connected Health Skillnet are hoping to offer this course in the near future. Register your interest today to be the first to hear about course dates.

Course Objectived and Content

By the end of this course, participants will:

• Understand IEC 62304:2015 and its role in medical software compliance.
• Gain familiarity with FDA, EU, and global regulatory requirements.
• Learn about AI/ML software and risk management for medical applications.
• Develop a strong foundation in cybersecurity and ISO 14971 risk management.
• Understand software lifecycle processes, from requirements to post-market activities.
• Acquire practical knowledge through real-world examples and hands-on exercises.

This course is regularly updated to reflect evolving industry standards and regulations. Key topics include:

• AI/ML Training Software & Risk Management – Managing risks in machine learning-based medical software.
• Iterative/Incremental Development & Compliance – Applying compliance principles to agile methodologies.
• FDA Premarket Submission Guidance – Latest updates and regulatory impact.
• Cybersecurity & Medical Software – Aligning with IEC 81001-5-1 for secure software development.
• ISO 14971 Risk Management – Detailed analysis of software hazards for Software as a Medical Device (SaMD).
• Regulatory Overview – Understanding US FDA and EU requirements.
• Types of Medical Software – Covering SaMD, HealthIT, AI/ML, mobile medical apps, and cloud services.
• Software Lifecycle Compliance – Applying IEC 62304 safety classes for prioritizing rigor and documentation.
• Software Verification & Testing – Automated testing strategies, unit verification, and test planning.
• Post-Market Compliance – Managing updates, rapid release cycles, and issue resolution.
• Workshops & Exercises – Interactive activities to reinforce learning.

Who should attend

Software developers, engineers, and testers working in medical device and HealthIT industries.

Regulatory and quality assurance professionals responsible for compliance and audits.

Product managers and software architects navigating medical software development.

AI/ML specialists involved in healthcare-related software applications.

Prerequisites

• Background in software development, quality assurance, or regulatory affairs.
• Basic understanding of medical device software development processes (helpful but not required).
• No programming experience required.

  Upcoming dates:

  No training dates available at the moment.