EN 62366 Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE) focuses on designing a user interface (UI) that allows people to quickly understand how to interact with a Medical Device (MD) in the most efficient and error-free manner. It supports the development of safe and effective medical design, by identifying and appropriately mitigating risks associated with usability. In …

FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation

On January 31, 2024, U.S. Food and Drug Administration (FDA) issued the following public announcement: “To ensure medical devices on the market are safe, effective, and of good quality, the U.S. Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision …

The Evolution and Impact of Software as a Medical Device (SaMD) in Healthcare

In recent years, the intersection of technology and healthcare has given rise to a transformative phenomenon – Software as a Medical Device (SaMD). SaMD refers to software intended to be used for medical purposes, without being part of a hardware medical device. This innovative approach to healthcare has reshaped the landscape of medical devices, offering …

MDSAP – MEDICAL DEVICE SINGLE AUDIT PROGRAM

The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in …