Guest Columns

  1. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation 7/23/2024

    In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

  2. How Early Talks With The FDA Can Pave Your DTx Approval Pathway 7/22/2024

    Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

  3. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

  4. Answer These Questions To Guide Your Prototyping Strategy 7/18/2024

    This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.

  5. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.