Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024....
On April 25, 2024, the European Commission issued a press release announcing that additional time will be granted to companies to transition to the...
Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice. FDA has published...
On March 13, 2024, the European Parliament approved the Artificial Intelligence Act (“AIA”), which represents the first comprehensive legal framework...
On January 31, 2024, the FDA issued its highly-anticipated Quality Management System Regulation (“QMSR”) Final Rule which amends current good...
Discover the essential steps for medical device manufacturers to ensure FDA regulatory compliance and quality standards.
On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical...
