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 ...

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, ...

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 ...

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 ...

Through a recent Gazette notification, the Ministry of Health and Family Welfare (Department of Health and Family Welfare) ...

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

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...