Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article ...

Brazil is rapidly establishing itself as a powerhouse in medical device innovation. This article shares market opportunities, ...

Whats the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and ...

Regulatory oversight and scrutiny of healthtech companies has emerged as a priority for the U.S. federal government. Facing triple investigations by the Federal Trade Commission (FTC), Department ...

There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.