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Usability, Requirements and IEC 62366-1

The easiest and fastest way to an IEC 62366-1 compliant usability file for medical devices

Abkürzung IEC 62366-1 auf einer Tafel

Acquire the prescribed qualification and learn to prepare the medical device suitability for use file and check it for "audit safety".

Has the issue of usability not been a particularly high priority for you so far? The notified bodies are increasingly scrutinising compliance with the legal requirement for usability. You can best comply with this if you adhere to the harmonised standards, especially IEC 62366-1.

The IEC 62366-1 standard places numerous requirements on the so-called usability-oriented development process. It calls for the close integration of this process with risk management. And it names many requirements for the suitability for use file. You will probably ask yourself how you can fulfil these requirements of the standard as quickly as possible and with the least effort. And at the same time also improve the usability of your products.


Depending on event location and date this seminar is available in German or English.

Target Audience

Product managers, CTOs, quality assurance staff, requirements managers, usability engineers

What You Will Learn

You learn...

  • how to structure the usability file
  • how to specify the requirements for usability
  • which procedures are used to verify and validate usability
  • how to create test plans and carry out and document usability tests
  • which contents you should document in which file (usability file, risk management file, quality management manual, etc.) and how you link between these files

Further contents of the seminar:

  • IEC 62366-1 and the usability-oriented development process
  • Interaction of IEC 62366-1 and risk management according to ISO 14971
  • Establishment of a usability file, documentation structure
  • Procedures for testing usability: Including inspection procedures (e.g. tests against style and design guidelines, ISO 9241, heuristics), participant observation (usability testing) and quantitative and qualitative user surveys.
  • Documentation of test specifications and test results

Your Trainer


2 days seminar plus 1 day practice workshop

  1. Day 1: 09.00 am till 05.00 pm (Seminar)
  2. Day 2: 09.00 am till 05.00 pm (Seminar)
  3. Day 3: 09.00 am till 04:30 pm (Practice workshop)

The maximum number of participants for a seminar is 10.


  • EUR 1,950 plus VAT (3 days)


This seminar is held at different locations and can also be booked as an inhouse seminar at your company. Please refer to the listing of dates for further details.

Dates for Seminar Usability, Requirements and IEC 62366-1

Our seminars are also available as in-house training, in English or German.  Get quote

Date Language Duration Location
22. May - 23. May 2024 English 2 days
Johner Institut GmbH Villa Rheinburg Konstanz
18. Sep - 19. Sep 2024 English 2 days
Online Zoom-Meeting
13. Nov - 14. Nov 2024 English 2 days
Online Zoom-Meeting


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