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The FDA’s 510(k) Pathway for New Medical Devices
The FDA’s 510(k) pathway is a critical regulatory route for bringing new medical devices to market in the United States.
Aug 15, 20243 min read
The FDA’s New Quality Management System (QSMR) Regulation
In a significant regulatory update, the FDA has introduced changes to the Quality Management System Regulation (QMSR).
Jun 26, 20242 min read
Modernizing Clinical Trials Through Wearable Technology, EHRs and Telemedicine
EHRs and innovative technologies like telemedicine and wearable devices are revolutionizing how clinical trials are conducted.
May 27, 20243 min read
Strategic Supplier Selection for Biopharmaceutical and Medical Device Enterprises
A sophisticated QMS is essential for supplier selection.
May 16, 20244 min read
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