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 ...

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

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 ...

Designers and engineers have often looked to the environment and how Mother Nature has accomplished phenomenal design solutions for inspiration over the ages. Perhaps all that is new about this ...

Medical devices play an essential role in improving the quality of human life. Consequently, their design poses unique engineering challenges. Designers must address high standards of reliability, ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

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 ...

Among the mechanical components that go into the design of the world’s two million different kinds of medical devices, consider the motor to be an unsung hero. Embedded inside a medical device, the ...

ORLANDO – During the HIMSS24 panel discussion "Securing the Modern Connected Hospital," James Angle, product manager of information security at Trinity Health, and hacktivist for hire Kevin Johnson, ...

Medical devices are revolutionizing healthcare. These devices improve patient outcomes, from tracking and recording vitals to measuring glucose levels to supporting cardiac conditions. The future of ...