Stay up-to-date with the latest news and articles written by our team of experts to assist medical device companies in navigating trends and challenges in regulatory affairs, quality management systems and clinical affairs.
In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable.
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device
An eQMS system, or electronic Quality Management System, is a software solution designed to automate
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs,
On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific
In an era where medical devices and pharmaceuticals are becoming increasingly complex, ensuring their safety
In an effort to streamline and enhance the evaluation of health technologies across Europe, the
In an era where artificial intelligence (AI) is rapidly transforming industries and societal norms, Canada
Are you ready for the FDA’s Quality Management System Regulation (QMSR) transition? The FDA’s new
