How to Accelerate Clinical Trials Without Compromising Data Integrity
In the fiercely competitive world of medical device development, speed to market is everything. But for regulatory professionals like myself, it’s a constant tightrope walk between accelerating clinical trials and ensuring bulletproof data integrity. At Bioexcel, I’ve found that accelerating clinical trials doesn’t have to mean cutting corners. The right systems and partners make it […]
The True Cost of a Compliance Failure: Financial and Reputational Damage Explained
In the medical device world, innovation gets the headlines—but compliance makes or breaks your business. And when compliance fails, the consequences go far beyond fines. For regulatory leaders like me, compliance isn’t a box to check—it’s the firewall protecting our reputation, our product, and our market access. The scary part? Most failures don’t come from […]
Flawless Regulatory Submissions: Avoiding the Most Common FDA and CE Approval Pitfalls
If you’ve ever had to rewrite a regulatory submission, respond to endless queries from a notified body, or watched a market launch get delayed over a minor documentation issue—you know this truth: Regulatory success isn’t just about product safety—it’s about submission precision. Whether it’s FDA 510(k), PMA, CE marking under MDR, or CDSCO approval in […]
Decoding Decentralized Trials: A Strategic Advantage for Medical Device Firms
As someone leading clinical operations and regulatory strategy, I’m always hunting for ways to run faster, smarter trials—without risking compliance or data integrity. That’s why decentralised clinical trials (DCTs) have captured my attention. And frankly, they should be on every medtech leader’s radar. Decentralised trials aren’t just a COVID-era buzzword anymore. They are a strategic […]
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 […]
