Question 1

When should usability engineering start in the design process?

Accepted Answer

At the very beginning — ideally before any user interface decisions are made. IEC 62366-1 requires a documented process from concept, and starting early means formative findings can actually change the design rather than just document what already exists.

Question 2

What is the difference between formative and summative testing?

Accepted Answer

Formative testing is iterative — conducted throughout design to identify and fix usability problems before they become risks. Summative testing is the final validation study that demonstrates your completed device is safe for its intended users. Only the summative evaluation is submitted to regulators, but formative evidence supports your UEF.

Question 3

Do you recruit test participants?

Accepted Answer

Yes. We handle participant recruitment against your defined user profile — including clinical professionals, lay users, or mixed populations as required. We manage screening, scheduling, consent, and facility coordination, so you can focus on the device.

Question 4

Which standards and markets do you cover?

Accepted Answer

Our programs are built to IEC 62366-1 as the primary standard, with alignment to FDA Human Factors guidance (for 510(k) and PMA submissions), EU MDR Annex I requirements, and MFDS expectations for the Korean market. We design one program that satisfies all three where possible.

Usability Engineering

Usability is not a UX exercise. It is a safety and regulatory requirement.

Usability Engineering Planning

Formative & Summative Testing

Usability Engineering File

Your Complete Usability Engineering File

Frequently Asked Questions

A summative test failure at submission costs you the entire submission cycle. A UEF that collapses under review costs you more.