Software Life Cycle Processes: Application of IEC 62304:2006 on medical device software

Training Course

Course Details

Event Scheduled: July 2026
Learning Mode: Online
Language: English
(see more details below)

Learning Objectives

This course provides useful operational tools for the application of the state-of-the-art IEC 62304:2006+A1:2015 standard "Medical device software - Software life cycle processes"

During this course, the participant will learn and discuss:

  • The requirements of the standard
  • Application of the standard
  • Medical software development and maintenance techniques

Who will benefit?

Product designers (software/hardware) and process engineering, quality system and product certification manager, consultants.

Course Agenda

  • Introduction
  • Notes on non-functional safety and functional safety
  • Notes on the condition of first failure
  • Software/hardware: principles of risk control
  • Notes on IEC 61508/VDE 801 Specific Techniques
  • IEC 62304:2006+A1:2015:
    • Requirements
    • Application

Prerequisites

Knowledge of ISO 13485:2016 and EN ISO 14971:2019 standards.

Learning Assessments

Upon completion, you will receive your globally recognised TÜV SÜD certificate of attendance on "The Medical Devices Regulation in Europe MDR EU/2017/745" training course.

Teaching Materials

  • Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
  • Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.

Learning Assessments

  • Certificate of competence, in case of successful completion of final exam
  • Certificate of attendance, in case of non successful completion of final exam or no exam

Duration

8 hours.

Scheduled Events

  • 06 July 2026, 09:00 am - 06:00 pm (CEST).

Price

950,00 € (per participant, taxation excl.)

Learning Mode

Online, Instructor-Led.
The course is held by a qualified TÜV Italia Akademie trainer.

Language

Training in English Language

Book now
or contact us at [email protected]

 

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