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 a significant move toward enhancing the safety and efficacy of machine learning-enabled medical devices
In response to increasing concerns over supply chain stability and its impact on healthcare delivery,
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across
The U.S. Food and Drug Administration (FDA) has issued its final guidance on user fees
The Therapeutic Goods Administration (TGA) is reaching out to stakeholders for feedback on a significant
The European Medicines Agency (EMA) is poised to introduce a new guideline aimed at establishing
The draft guidance document titled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs
The FDA’s draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented
In a significant stride towards enhancing global healthcare standards, the World Health Organization (WHO) has
