In this article, you will learn about the requirements that the FDA places on human factors engineering (HFE), the products to which the FDA applies these requirements, and how you can implement these requirements.
What are primary users? What are secondary and even tertiary users? What specific requirements do regulations place on these user types, particularly the FDA and IEC 62366? Should we talk about users, operators, or consumers? This article provides answers.
Many companies confuse “user experience” with “usability,” which leads to confusion not only during audits. This article distinguishes between the two terms and reveals how you can test both.
A usability lab is a facility where usability experts can simulate user environments to review the usability of products using usability tests. This involves asking test subjects (test participants) to complete tasks using these products. In this article, you will learn
DetailsThe NMPA Usability Guidance affects many manufacturers of medical devices and IVDs, as well as manufacturers of combination products, who want to market their products in China. This article clarifies which devices must comply with the NMPA requirements regarding usability and what these requirements are.
DetailsThe term summative evaluation can be translated as “final evaluation.” A summative evaluation checks at the end of the development phase whether users can operate a device or a user interface safely. This article provides an overview of the regulatory requirements for the “summative evaluation” (sometimes also referred to as “summative assessment“) and gives you…
DetailsThe FDA describes its requirements for Human Factors Engineering in two documents: This article
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA recognizes critical (user) tasks. In development, use cases and user stories are used. This variety of terms makes it difficult to achieve a common understanding. However, this is necessary to create a consistent and legally compliant usability engineering file and avoid regulatory problems. This…
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development, one works with use cases and user stories. This diversity of terms makes a common understanding difficult. However, this is necessary to create consistent and legally compliant usability files and to avoid regulatory problems. This…
DetailsThe regulations relevant to usability engineering require formative evaluations.
