The FDA’s CDRH has launched a pilot program to accelerate public communication of high-risk medical device recalls. Learn what this means for manufacturers and how to prepare your recall and risk management systems. […]

The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political shifts, leadership changes, and funding concerns, the regulatory landscape is facing potential disruptions that could impact companies operating in the life sciences space. Understanding these [...]

The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations and patent protections often demands significant expertise and foresight from industry stakeholders. […]

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current Quality System Regulation (QSR) and align with ISO 13485:2016, marking a notable evolution in quality [...]