Guest Columns

1. The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025 12/10/2024

   Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

2. Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions 12/9/2024

   In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

3. How To Prevent Device Misuse Through Formative Studies 12/9/2024

   While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

4. 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.

5. 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.

6. 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. 

7. 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.

8. 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.

9. 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.

10. 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.