PMCF vs. PMS: What You Must Know to Stay Compliant Post-Launch
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 get these wrong. If I miss a requirement or confuse one for the other, we’re looking at delays, audit findings, […]
The Clinical Development Plan: Your Strategic Blueprint for MDR Compliance
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 14155-compliant CDPs from Bioexcel assist medical device innovators in streamlining regulatory approvals, reducing risk, and assuring continuous learning throughout the […]
The Biggest Quality Challenges for Medical Device Companies in 2025
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 quality management systems (QMS) to comply with expanding regulations like the EU MDR and FDA updates. Compliance is necessary for […]
From Bench to Market: The Complete Medical Device Development Lifecycle Explained
Introduction The path from lab to market for a medical gadget is tortuous and full of turns. It begins with research and development, then abruptly enters a maze of regulatory clearances, followed by continual checks after launch. Each stage is crucial to patient safety and device functionality. Protecting against risks requires quality risk management (QRM). […]
Clinical Evaluation Report (CER): A Critical Component for EU Market Access
Introduction The Clinical Evaluation Report (CER) is more than just regulatory paperwork—it helps medical devices enter the EU market. This report describes a device’s safety and performance qualities while following high European standards, usually ensuring that even new inventions meet standards. When the European Commission strikes a balance between ambitious innovation and precaution, the CER […]
Designing Clinical Trials for CE Marking: Best Practices for EU MDR Compliance
Introduction Medical device control has clearly changed since the European Union unveiled the Medical Device Regulation (EU MDR). Clinical studies aiming at that CE mark now have to follow a stricter game plan; it’s not only about crossing off a compliance list but also about ensuring gadgets operate safely for patients. Putting strong, evidence-based trial […]
Real-World Evidence in Clinical Trials: Boon or Burden?
Introduction Clinical researchers increasingly use Real-World Evidence (RWE) to gather data on real-world patient outcomes. RWE gathers clinical data from common healthcare settings, unlike RCTs, which are rigorously controlled. Demand for more inclusive, efficient, and economically feasible evidence generation drives this evolution. But this change brings up an important question: is RWE a revolutionary step forward in clinical trials, or does it add new problems that make things more difficult for everyone, like data integrity, legal uncertainty, and the need for rigorous analysis? The goal of this blog is to look at both […]
Post-Market Clinical Follow-up (PMCF): A Strategic Approach to MDR Compliance
Ensuring medical devices follow the Medical Device Regulation (MDR) and maintain patient safety and device performance on track depends critically on Post-Market Clinical Follow-up (PMCF). The healthcare sector is always changing, and as guidelines get more complicated, people using new technology sometimes find unanticipated difficulties. If new technology is going to flow into daily use […]
Suture and Wound Care Device EU MDR Compliance: Why PMCF and ISO 14155 Matter?
The European Union Medical Device Regulation (EU MDR) has become very important for regulatory managers, clinical operations teams, R&D professionals, and leaders in companies that make sutures and wound care products. New strict rules were put in place by the EU MDR that affect even well-known goods like surgical sutures and wound care devices. This […]
A Regulatory Requirement for Orthopedic Implants: Post-Market Clinical Follow-Up (PMCF)
Introduction: Why Orthopedic Implants Need PMCF Particularly for high-risk products like orthopedic implants, regulatory authorities all around are tightening post-market surveillance (PMS) criteria. Manufacturers under EU MDR (2017/745) and ISO 14155:2020 have to carry Post-Market Clinical Follow-Up (PMCF) to guarantee long-term safety, effectiveness, and performance. But why for orthopedic implants is PMCF non-negotiable? And how […]
