Regulatory & Compliance Perspectives

  1. New Sustainability Mandates In Brazil And Chile Are Quietly Disqualifying Medical Devices 4/15/2026

    The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment; it represents a structural market transformation. 

  2. How To Stop (Most) Medical Device Recalls Before They Happen 4/8/2026

    Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.

  3. The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail 2/20/2026

    While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. AI Enters The 510(k) Submission World: What Device Developers Need To Know 12/15/2025

    The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.

  10. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.