Safety Standards 2 days (14h)

IEC 62304 (Medical)

Master the life-cycle processes and activities required for medical-device software under IEC 62304.

Course Description

This IEC 62304 training gives medical-device engineers a practical understanding of the software lifecycle required for safe, regulated medical device software.

Pedagogical Objectives

By the end of this course, participants will be able to:

  • Understand the general principles of IEC 62304.
  • Position IEC 62304 within the medical ecosystem and identify its links with other standards and reference documents.
  • Interpret the requirements of the standard.
  • Plan the detailed actions and verifications to carry out for each part of the software life cycle.
  • Select tools to automate certain activities and gain efficiency.
  • Use Software of Unknown Provenance (SOUP) and legacy software while meeting medical-device certification constraints.

Course Program

  • Introduction to software quality assurance.
  • General concepts and links with the other standards in the field.
  • Software safety classes: definitions and methodology for determining safety classes.
  • Software risk-management process: contribution to hazardous situations; risk-control measures.
  • Software development process.
  • Software maintenance, configuration-management and problem-resolution processes.

Related Expertise

Request Information on IEC 62304 (Medical)

Fill out the form below to request information on this training or a custom session for your team.







    View All Training