Guest Columns

31. EC Rep To EU Rep: The Symbol Shift You Can't Ignore 4/23/2025

    The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.”

32. A Proactive 6-Point Approach To Security For Neurotech Developers 4/17/2025

    There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

33. Unlocking The Potential Of Sensor-Based Digital Health Technologies For Mental Health Conditions 4/9/2025

    Sensor-based digital health technologies (sDHTs), including wearables, have great potential in the management of mental health conditions like anxiety, depression, and psychosis. Patient-centered design is key.

34. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

35. The Latest Developments And Challenges With EU Medical Devices Legislation 4/4/2025

    Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments and what is important to know when seeking to do business in the EU.

36. Struggling With GxP Systems? There's A DAP For That 4/2/2025

    A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

37. Risk Management Planning: Be Prepared When Disaster Strikes 4/1/2025

    Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

38. The Future Of Medical Device Labeling Is Here 4/1/2025

    Medical device labels that lack information or contain inaccurate information may lead to product recalls or delays in product release. Generative AI offers a solution to streamline the labeling development process. 

39. Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K. 3/26/2025

    Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.

40. HLA Typing For HSCT: New Research Indicates Expanded Patient Compatibility 3/20/2025

    A challenge in hematopoietic stem cell transplantation (HSCT) is finding a fully matched unrelated donor. Recent advances in research and human leukocyte antigen (HLA) typing are allowing more patients to be matched.