Regulatory & Compliance Perspectives

  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 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.

  5. 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.

  6. 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.

  7. 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.

  8. The U.K.'s MHRA Adds New Guidance To The Changing Regulatory Landscape For Digital Mental Health Technologies 12/12/2025

    The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies qualify as medical devices based on their intended purpose and functional impact. 

  9. Wearable Medical Devices — What Should Your Contracts Look Like? 12/1/2025

    Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.

  10. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”