Guest Columns

  1. Critical Considerations For IP & Patents For Emerging Medical Device Companies 7/11/2025

    As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning patents — are critical for medical device innovators and manufacturers.

  2. Brazil's Competitive Edge: Infrastructure And Operational Advantages For Medical Device Trials 7/10/2025

    Explore the practical advantages that position Brazil at the forefront of medical device clinical trials in the region.

  3. 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.

  4. 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.

  5. Designing Wearables That Are Truly Patient-Centric 7/7/2025

    There’s a distinct need to create wearables that interweave seamlessly into an individual’s lifestyle, encouraging adherence and gathering long-term, accurate diagnostic data.

  6. 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.

  7. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

    Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

  8. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

    A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

  9. 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.

  10. 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.