Regulatory & Compliance Perspectives

  1. 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.

  2. Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance 7/7/2025

    The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.

  3. Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials 7/3/2025

    Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.

  4. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

  5. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

  6. Key Regulatory Landscapes For SaMD Around The World 6/13/2025

    As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are evolving to keep pace.

  7. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  8. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

  9. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2 5/13/2025

    This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.

  10. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

    This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.