Training - Putting the medical standard IEC 62304

Duration: 2 days

Date: On request

Type: Inter- and Intra-company

Level: Software Quality Assurance Manager, Software Development Engineer...

Course material : French

Location: In our branches, on site or remotely

Our commitments

  • Customised services (in-house)
  • An enhanced offering based on our experience feedback and market technology watch
  • Speakers with engineering backgrounds and proven operational experience
  • Practice-oriented training
  • Over 20 years' experience in risk and operational safety training....
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This training course will enable you to assimilate the fundamental principles of the IEC 62304 standard, which governs the lifecycle process for software embedded in medical devices.

It will focus on teaching the most appropriate implementation methodologies for certifying medical device software.

Participants / Prerequisites

Knowledge of programming languages and standards relating to the medical sector.

Learning objectives

This training course will teach you :

  • The general principles of IEC 62304
  • The link with other standards and reference documents in the field (IEC 60601-1, IEC 82304-1, etc.)
  • Details of the tables of requirements in standard IEC 62304
  • Details of the actions to be taken and the checks to be carried out for each part of the software lifecycle
  • How to use Software of Unknown Provenance (SOUP) or COTS in your medical device, while ensuring the system's certifiability
  • How to integrate automated tools to help throughout the development cycle


Developments in the medical device manufacturing sector

Introduction to Software Quality Assurance

IEC 62304 : General and links with other standards

IEC 62304 : Software safety classes

Software risk management process

Software development process

Software maintenance process

Software configuration management process

Presentation of a software configuration management process
Steps in the configuration management process
Modification and version management

Software problem-solving process

Principle and implementation
Distinction between software maintenance and problem solving

IEC 62304 and use of SOUP or COTS

Links with IEC 60601-1, IEC 61010 and IEC 82304-1


Course material is given to each trainee in pdf format.


As a leading engineering and consulting company, we have been supporting our clients, both large accounts and SMEs, since 1989.
With a close presence in France and abroad, we enable them to study, design or develop their products.

Mediane  Systeme, expertise on a human scale.

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