Developing Medical Device Software According to IEC 62304

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Course Duration: 2 Days - 8 Hours/day

This two-day course is designed to give the attendee a detailed understanding of developing and maintaining Medical Device Software following the requirements of IEC 62304. The course covers the relationship of IEC 62304 with related standards such as ISO 13485, ISO 14971 and IEC 60601.

Learning Objectives

  • Detailed understanding of IEC 62304 
  • Software Development Processes for Medical Devices
  • Software Maintenance Processes for Medical Devices 
  • Support Processes influencing Medical Device Software Development
  • Relationship of IEC 62304 with related standards

Day One

 Chapter 1: Introduction and Overview

o   Definition

o   History

o   Structure

o   Key Concepts

o   General Requirements and Software Safety Classification

  Chapter 2: Initiation of Software Development

o   Software Development Planning and New Product Development

o   Deriving Software Requirements from System Requirements through Software Requirements Analysis

o   Breakout Exercise: Writing Effective Software Requirements for Medical devices

 Chapter 3: Software Design

o   Software Architectural Design

o   Software Detailed Design

o   Breakout Exercise: Architectural Design


Day Two


 Chapter 4: Software Verification and Testing

o   Unit Implementation and Verification

o   Integration and Integration Testing

o   Software System Testing and Release

§ Relationship to IEC 60601 – General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment

o   Breakout Exercise: Testing for Medical Device Software using Test plans

Chapter 5: Software Maintenance Process

o   Maintenance Planning, Problem Analysis and Modification Implementation

Chapter 6: Supporting Processes

o   Software Risk Management (and relationship to ISO 14971)

o   Changes and Configuration Management

o   Issue Resolution Process

o   Breakout Exercise: Performing Software Risk Management

Chapter 7: Integrating IEC 62304 into Medical Device Companies

o   Integrating with ISO 13485 – Medical Devices Quality Management System

o   Breakout Exercise: Integration of IEC 62304 into your Organization’s Quality Management System

Developers, project managers, software quality engineers and managers & other participants involved with the development of embedded software systems in the medical industry.

Test engineers, hardware quality engineers, hardware quality managers, and other participants involved with development of embedded systems in the medical industry will also find this course beneficial.

IEC 62304 implementers, internal auditors, and others who need to understand IEC 62304 and how to integrate it into their Quality Management will find the training helpful. 

Each participant will receive a seminar manual including case studies. 

Background in development projects, software development, quality management systems, or medical device systems is beneficial.

A basic understanding of project management, quality management and system and software engineering processes is also helpful, but not required.

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