Guest Columns

41. How To Navigate Clinical Data Per EU MDR 4/7/2021

    The EU MDR puts a higher emphasis on clinical data for medical devices and calls for increased scrutiny on the duty of manufacturers to continuously collect clinical data in the postmarket setting. Matthias Fink, MD, of TÜV SÜD America explains the MDR requirements surrounding clinical data.

42. Rating Risk Events: Why Adjusted Risk Likelihood (ARL) Should Replace Risk Priority Number (RPN) 4/7/2021

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

43. 10 Actions To Prepare For The U.K. Conformity Assessment Process 4/5/2021

    The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the MHRA. Discover the 10 actions you should take to prepare for the U.K. Conformity Assessment process.

44. Implementing EU MDR and IVDR: Lessons Learned, Part 2 3/31/2021

    The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

45. AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval 3/29/2021

    Application of artificial intelligence (AI) and machine learning (ML) in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. By digesting the different jurisdictional AI/ML regulatory frameworks that have been released (draft or enforceable), along with personal experience with the agencies, John Giantsidis, president of CyberActa, Inc., identifies the common denominators crucial to success.

46. Life Sciences Deal-Making Gets Creative, Aims At Early Stages Amid COVID-19 3/29/2021

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook

47. Implementing EU MDR and IVDR: Lessons Learned, Part 1 3/24/2021

    The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!

48. 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.

49. 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.

50. 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.