Industry Perspectives

  1. Improving Medical Device Testing With Robotic Automation 9/25/2024

    Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.

  2. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

    This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

  3. Does My Medical Device Design Actually Work? 8/6/2024

    In medical device development, the proof of feasibility stage often includes preliminary testing, but also detailed technical, usability, manufacturability, regulatory, and commercial assessments.

  4. Q&A: Micro Molded Thin-Wall Cannulas 7/30/2024

    Discover how Accumold's approach is setting new standards in medical device manufacturing and what it means for the future of wearable health technology.

  5. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

  6. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

  7. Is Your Lab Ready For A LIMS Implementation? 7/25/2024

    Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.

  8. 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.

  9. 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.

  10. 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.