Regulatory & Compliance Perspectives

31. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

32. Data-Driven Trends In Predetermined Change Control Plans 7/12/2024

    The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.

33. Understanding The Potential Of AI Med Devices Amid Regulatory Challenges 7/9/2024

    As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance.

34. Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines 7/8/2024

    This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.

35. Is Mexico A Prime Location For Medical Device Clinical Trials? 6/27/2024

    Mexico, one of Latin America's largest economies and most populous countries, is emerging as a prime destination for medical device clinical trials and other advanced medical technologies.

36. Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm 6/6/2024

    The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.

37. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

    There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.

38. 5 Innovative Ways To Bring DHTs To Market Successfully 5/30/2024

    Real-world examples demonstrate how digital health technology (DHT) developers can navigate the regulatory pathway while optimizing opportunities for downstream patient access.

39. Clinical Investigation Plans: The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV, ISO 14155 5/22/2024

    The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How does it complement existing guidance and regulation?

40. What You Should Know About The FDA's New Final Rule On LDTs 5/14/2024

    The FDA made a small change with big consequences when it amended its definition of in vitro diagnostics. Here’s what it means for lab-developed tests.