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  • Adapting to FDA Shifts: How to Stay Ahead

    The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political shifts, leadership changes, and funding concerns, the regulatory landscape is [...]

  • Navigating the Complexities of Combination Product Regulations and Patents

    The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations [...]

  • Getting QMSR Ready: Key Changes and Steps to Prepare for the February 2026 Deadline

    With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current [...]

  • Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare

    Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and [...]

  • Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

    The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination [...]

  • Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments

    Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to [...]

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