Guest Columns

1. Building The AI-Enabled Medical Device QMS For European Compliance 2/6/2026

   Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards.

2. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

3. Navigating Brazil's Medical Device Clinical Trial Import Process 1/27/2026

   When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

4. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

   The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.

5. Why Use Total Organic Carbon Analysis For Cleaning Validation? 1/21/2026

   Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

6. The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America 1/13/2026

   Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.

7. Conducting A Medical Device Stability Study: A Practical Guide 1/7/2026

   Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

8. Electronic Drug Delivery Devices Market: Advancing Smart, Connected Healthcare 12/19/2025

   What is factoring into market growth for electronic drug delivery devices and why? New market research shares key insights.

9. Digital Surgery In 2026: The Data-Driven Operating Room 12/18/2025

   The operating room has evolved beyond just a sterile environment. Digital surgery in 2026 will be defined by the convergence of data, devices, and digitization.

10. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.