The EUs Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is ...

One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an ...

Optical micro overmolding combines micro molding with lead-frame or insert processes to achieve precision, clarity, and ...

Learn how to be more proactive by implementing robust PFAS testing and control strategies to safeguard patient health, ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...

Part 1 of this series presented factors that medical device developers should consider when executing HFE studies internally, detailing how to overcome obstacles while acknowledging that executing ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...