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 …

Medical Device Software Life Cycle Management

The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing software and standalone software which are considered as medical device in line with the Article 2 of the MDR. EN/IEC 62304:2006/A1:2015 is a basis standard which defines requirements for Medical Device Software Life Cycle Processes. In addition …

US FDA 510 K Submission – How to prepare a 510 K File?

Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. In that sense, FDA 510 K clearance is required for …

FDA Biocompatibility Assessment Resource Center

FDA issued a new page called “Biocompatibility Assessment Resource Center”, where you can find useful information for your biocompatibility evaluation. The web pages mainly include explanation of terms and concepts important for a biocompatibility evaluation of a medical devices.  As you might already know, the general principals are already specified in the guidance document “Use …

EMC of Medical Devices – Draft FDA Guidance

EMC of Medical Devices – 510 K Content For active medical devices, the EMC information is an important part of the 510 K file. Currently the required information is listed on the guidance document “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”  issued on July 2016. FDA issued recently a …

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 …

Surgical Mask – FDA Issues Umbrella EUA

On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel …