Eli Lilly and Companys one-team mindset aims to templatize facility design while remaining nimble enough to react to new ...

DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in ...

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

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 ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

Disclaimer: The following article provides an overview of the medical coding and billing systems used in the U.S. as part of the traditional fee-for-service billing model. It does not cover durable ...

Surgical navigation and robotic systems are not novel technologies and have had a historical presence since the 19th century. Surgical navigation is a result of evolution from a frame-based stereotaxy ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...