Blogs

Introduction Determining the right sample size is a critical step in designing any clinical trial, and medical device studies are no exception. How many patients do we need? is not just a statistical question –...

Introduction When testing a new medical device, ensuring it is not only effective but also usable and safe in the hands of real-world users is paramount. Human factors (HF) engineering – sometimes called usability engineering...

Introduction Within the field of medical device trials, ISO 14155:2020 serves as the definitive guideline for Good Clinical Practice (GCP). This international standard, titled “Clinical investigation of medical devices for human subjects – GCP”, demystifies...