Here you will find information on the usability / human factors engineering of medical devices and regulatory requirements such as FDA and IEC 62366

Usability Testing in Times of Corona

Manufacturers cannot simply not carry out usability tests in the time of corona. Both IEC 62366-1 and the FDA insist on these tests. And there are no exceptions because of the coronavirus more...

Market Research

Market research is the systematic collection and evaluation of market data (e.g., from customers and the competition) with the aim of making the right decisions with regard to the development and modification of devices, marketing actions and much more...

Heuristic Evaluation

Heuristic evaluation is a process which usability experts use to assess the usability of products by means of heuristics more...

User Stories: Mind issues with regulatory compliance

Medical device manufacturers, in particular software developers, frequently employ user stories to derive respectively to document requirements. Manufacturers should keep regulatory requirements in mind when doing so. Learn more about the traps with user stories.

Main Operating Functions

The IEC 62366 formulates requirements for the main operating functions of medical devices. Unfortunately, they do not define the term function and causes confusion. This article provides a definition and examples of medical products main operating functions more..

ISO 9241

The ISO 9241 is an entire family of standards originally from the "Ergonomic requirements for office work with visual display units”. Meanwhile, the applicability of ISO 9241 has further developed to every form of products more..

Usability Validation

The usability validation is a test with objective means, whether the specified users can reach the specified user objectives (intended use) effectively and efficiently more..