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 ...

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 ...

The MarketWatch News Department was not involved in the creation of this content. Arlington, Virginia--(Newsfile Corp. - November 18, 2025) - How medical professionals interact with medical devices is ...

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 ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...