Guest Columns

31. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

    FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

32. What's Trending In Medical Devices And Diagnostics For 2025? 12/4/2024

    Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will drive innovation and reshape clinical research in 2025.

33. A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests 12/3/2024

    Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with regard to medical device regulations that would otherwise apply to labs that prepare and/or market LDTs. 

34. Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies 11/25/2024

    The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

35. Medtech: Capitalize On These 4 Trends To Thrive In 2025 11/21/2024

    Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy medtech companies will seize for success in 2025.

36. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

    Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

37. How The EU AI Act Impacts Medical Device Manufacturers 11/18/2024

    The EU AI Act is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries. Here's how it impacts medical device manufacturers.

38. We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead 11/13/2024

    The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.

39. Increasing Diversity In Medtech Innovation: A Personal And Professional Perspective 11/11/2024

    The author describes the hurdles with medtech innovation driven by homogenous groups and some practical strategies for the industry to improve diversity.

40. How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? 11/5/2024

    Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.