Guest Columns

31. 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. 

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

    Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.

     

38. Mastering FDA Inspections: The Prep Work For Regulatory Success 2/21/2025

    In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product quality, operational efficiency, and patient safety. Shift from a reactive to a proactive mindset.

39. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

40. Growth And Advancements In Transdermal Drug Delivery 2/19/2025

    The transdermal drug delivery system industry is seeing significant growth. Let's look at new market research, including the advanced technologies being used and the therapeutic areas seeing the most impact.