Blogs

If you’re managing regulatory strategy in a medical device company, you’ve likely heard both terms—Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS)—used interchangeably. But they’re not the same. What I’m thinking: I can’t afford to...

Introduction: Why a Clinical Development Plan Matters The Clinical Development Plan (CDP) is essential to your device's clinical evaluation under EU MDR 2017/745. It supports comprehensive clinical evidence from feasibility studies to post-market real-world observations.ISO...

Introduction Medical device firms trying to innovate while meeting strict regulatory criteria face several quality issues as the industry changes rapidly. As mentioned in (Challenges Q in the 2025 Industry MD), organisations are upgrading their...