Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

A technician at Microtest performs bioburden testing using the aseptic technique. There are no commonly accepted levels of environmental bioburden. Industrial sterilization and contamination control ...

EGLIN AIR FORCE BASE, Fla. — Team members with the U.S. Army Medical Materiel Development Activity braved the arctic cold and hurricane force winds as part of environmental testing held July 11-15, ...

In recent years, the presence of per- and poly-fluoroalkyl substances (PFAS), commonly known as "forever chemicals," in medical devices has become a growing concern. Used for their durability, these ...

Even though the FDA recently began an open dialog with the wireless medical device community over mHealth regulation, enforcement of federal quality regulations at labs that develop medical devices ...

Objective Medical devices account for approximately 6–10% of national health systems’ carbon footprints. The global use of single-use devices has increased, with implications for health systems’ ...

The Centre plans a major overhaul of India’s medical device regulatory framework by removing expiry-based licences and introducing perpetual approvals, along with standardised laboratory testing norms ...

Regulatory overhaul aims to cut compliance burdens, improve safety, and attract investment in India’s $15B medical devices ...