Clinical Evaluations and the EU Market
February 21, 2024
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.
Clinical evaluation is arguably one of the most important topics in the international medical device
In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k)
While the European Union (EU) remains hard at work in developing its new regulatory framework
On January 23rd, amid concerns that there is not enough time for manufacturers to comply
The world of technology is moving at lighting speed. We are experiencing advances in software
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe
Recent trends in clinical studies, including the nearly ubiquitous move to electronic data capture (EDC)
