Guest Columns

31. 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.

32. 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.

33. 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.

34. 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.

35. 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. 

36. 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.

37. 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.

38. Key QMS Considerations For Your Medical Device Startup 3/17/2025

    A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and provides information to help you make the right decision for your medical device company.

39. A Look At AI-Driven Medtech For Rare Disease Diagnosis 3/12/2025

    Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming rare disease diagnosis.

40. Lessons Learned From Vivani Medical's Study Of GLP-1 Implant 3/5/2025

    Vivani Medical Cofounder and CEO Adam Mendelsohn, Ph.D. discusses the company’s first application of the NanoPortal, including its upsides for patient adherence, its optimized trial design,  and its reception among sites and patients.