Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.

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 ...

Opportunities lie in offering comprehensive training on global human factors and usability regulations for medical devices, focusing on user-centered design and post-market surveillance. This ...

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 ...

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 ...

The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...

Compremium’s Quantis CVP joined the FDA’s Total Product Life Cycle Advisory Program (TAP) after earning Breakthrough Device ...

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 ...

Structural flaws are hiding in plain sight, and a shift is long overdue, writes Pujitha Gourabathini at Becton, Dickinson and ...

It's not enough anymore for connector suppliers to just make products, especially when it comes to medical devices. Design engineers at device OEMs are asking their connector suppliers for a lot more ...