ANSI/AAMI HE75:2025; Human factors engineering - Design of medical devices is the first update to AAMI's premier human factors standard since 2009. The standard is meant to assist users and ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Successful new medical devices hinge on the designer’s understanding of the specific requirements of the procedures they support, including factors like usage frequency and duration. This is ...

Rapid advancements in medical device technology have brought unprecedented changes to the industry. Increasingly, innovative medical devices also combine developments from other industries such as ...

LAKELAND, Fla., Oct. 12, 2021 /PRNewswire/ -- SteriPack Group ("SteriPack"), SteriPack, a leading global contract manufacturing service provider to the medical device, diagnostic and pharmaceutical ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

This course builds on the work done in BMEN.4030, Medical Device Design I. The course focuses on moving one or more potential solutions to a medical need forward into technical development and ...

This certificate program is designed to prepare biomedical engineers to understand the environment into which their innovations will be placed and the users who will interact with them. Professionals ...

Secure by design didn’t just pop up in the medical device industry with the update to the Food & Drug Administration (FDA) guidance on cybersecurity recommendations. However, its inclusion in this ...

Each year, the Yale School of Engineering & Applied Sciences offers a popular course in medical device design. This semester, “Medical Device Design and Innovation” — cross-listed under the ...

Medical devices encompass a range of products, from ultrasound equipment and implantable devices to home blood glucose meters and fitness trackers. Each application calls for different requirements, ...