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 ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

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 ...

The pandemic has forced remote product development in many fields, and the medical device arena has seen rapid growth in the use of virtual reality (VR). Studying the potential outcomes for individual ...

In the labyrinthine world of medical device manufacturing, process is king—but culture wears the crown. Peter Drucker's adage, “Culture eats ...

Newly revised "model contract language" guidance from the Health Sector Coordinating Council provides an updated reference document to help healthcare ...