According to the Swiss association for medical technology companies, Swiss Medtech, introducing the new European regulations for medical devices (MDR) and in vitro diagnostics (IVDR) is going to have ...
The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...
Switzerland's years-long standoff with the European Union over a stalled bilateral treaty could soon have real-world impact by triggering shortages of medical devices that now trade seamlessly across ...
“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...