Guest Columns

1. The U.K. Now Classifies Ambient Voice Technology As SaMD 8/14/2025

   The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD). 

2. The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us 8/12/2025

   FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.

3. Improving Drug-Device Combination Product Co-Development 8/8/2025

   Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

4. Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials 8/7/2025

   This article explains why Latin America's demographic diversity, cost profile, and accelerating digital health infrastructure make it an ideal region for AI-enabled medical device clinical trials. 

5. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

6. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

7. Medical Device Innovation In Brazil: Success Stories And Future Opportunities 7/28/2025

   Brazil is rapidly establishing itself as a powerhouse in medical device innovation. This article shares market opportunities, success stories, and strategic recommendations for medical device manufacturers.

8. Critical Considerations For IP & Patents For Emerging Medical Device Companies 7/11/2025

   As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning patents — are critical for medical device innovators and manufacturers.

9. Brazil's Competitive Edge: Infrastructure And Operational Advantages For Medical Device Trials 7/10/2025

   Explore the practical advantages that position Brazil at the forefront of medical device clinical trials in the region.

10. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.