Aug 153 minWearable TechnologyThe FDA’s 510(k) Pathway for New Medical DevicesThe FDA’s 510(k) pathway is a critical regulatory route for bringing new medical devices to market in the United States.
Jun 262 minRegulatory ComplianceThe FDA’s New Quality Management System (QSMR) RegulationIn a significant regulatory update, the FDA has introduced changes to the Quality Management System Regulation (QMSR).
May 273 minWearable TechnologyModernizing Clinical Trials Through Wearable Technology, EHRs and TelemedicineEHRs and innovative technologies like telemedicine and wearable devices are revolutionizing how clinical trials are conducted.
May 164 minStrategic Supplier Selection for Biopharmaceutical and Medical Device EnterprisesA sophisticated QMS is essential for supplier selection.