Regulatory & Compliance Perspectives

1. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

   The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

2. Why Your LATAM Authorized Representative Strategy Is A Market Entry Decision, Not A Clerical One 6/18/2026

   Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset becomes the operational choke point for importation, renewals, and more.

3. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

   Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

4. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

   Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

5. Risk Is the Spine: What The First 100 QMSR Inspections Reveal 5/29/2026

   The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

6. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

   FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

7. The QMSR's Hidden ROI: LATAM's Device Trial Advantage 5/18/2026

   The FDA's new QMSR quietly created a harmonized quality framework between the U.S. and Latin America. With high recruitment performance and low cost, conducting medtech trials in the region has key benefits.

8. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

   Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

9. Complaints Into Practical Action: Human Factors Drug Delivery 5/5/2026

   Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.

10. Minding The Gap: Submission Strategies For Combined Use Combination Products 4/17/2026

    For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.