Guest Columns

  1. Medtech Key Target Of Upcoming Regulation Of Ethical AI In The EU 3/22/2021

    In the EU, the first official draft proposal for the regulation of ethical artificial intelligence (AI) is expected in late April 2021. By examining the initial draft proposal published in October, we learn what will be regulated and how it will be regulated in the medtech sector.

  2. Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success 3/17/2021

    Each year, the FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations. This article presents background and high-level observations on the inspection data over time, revealing 3 key takeaways.

  3. Establishing An Effective Calibration Program 3/15/2021

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

  4. A Look Ahead: US FDA And Medical Device Regulations In 2021 3/10/2021

    Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article explores some of the FDA initiatives and activities worth following this year. 

  5. The 6-Step Checklist For IVDR Compliance 3/8/2021

    The in vitro diagnostic devices industry has until May 25, 2022, to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017. Are you ready?

  6. Statistics Abuse In QA/QC: 3 Lessons Learned 3/3/2021

    One of the best tools at our disposal in a quality assurance/quality control context (manufacturing, supplier quality, etc.) is statistics. However, you should use caution and be mindful that you use it correctly and effectively. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, shares his 3 lessons learned.

  7. Introduction to Injection Mold Verification 3/1/2021

    Throughout Zachi Fizik's article series, he has focused on plastic parts used in your medical device and the associated mold production process. In this article, he explains the difference between T0 and T1, which is the first trial. He also discusses sending T1 remarks to the mold maker. With a combination of experience and agility, you'll be able to approve final samples in a timely manner.

  8. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III 2/26/2021

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.

  9. Answer These 3 Questions Before Developing Software As A Medical Device 2/22/2021

    Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.

  10. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

    Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.