The Clinical Trial Roadmap for Medical Devices: From Pilot to Pivotal
Introduction: Developing a medical device from an initial concept to a market-approved product is a journey that involves multiple stages of clinical research. Unlike pharmaceuticals (with Phase I–III trials), medical devices typically progress through a pilot (feasibility) study followed by a pivotal trial before approval. Each stage has a distinct purpose: the pilot stage uncovers […]
FEATURED: The Clinical Development Plan – A Strategic Imperative Under EU MDR
Dear Innovator, Are you preparing your medical device for EU MDR compliance? The Clinical Development Plan (CDP) is more than just a regulatory formality—it’s your blueprint for generating meaningful clinical evidence. At Bioexcel, we help you draft and execute MDR-aligned CDPs that accelerate your path from first-in-human trials to post-market follow-up. What’s Inside a Strong […]
What Auditors Look for in Clinical Trials—and How to Stay Ahead
When you’re leading clinical operations and regulatory compliance like I am, there’s one scenario that plays in your head more often than you admit: The knock on the door. The demand for documentation. The fear they’ll uncover something we missed. Audits—whether by the FDA, CDSCO, CE bodies, or internal QA teams—are intense. But they don’t […]
Everything You Need to Know About the Materiovigilance Programme of India (MvPI)
What is Materiovigilance? In the medical world, it’s not just drugs that need monitoring — medical devices also come with safety concerns. Materiovigilance refers to the systematic monitoring, recording, and assessment of adverse events or risks related to medical devices after they’ve been placed on the market. In India, this crucial responsibility is handled under […]
Global Regulatory Compliance: Building a Single Strategy for FDA, CE, CDSCO & ISO 13485
When you’re responsible for clinical and regulatory strategy, juggling multiple submissions across geographies is more than a challenge—it’s a minefield. With the FDA tightening review timelines, CE MDR requirements expanding, CDSCO demanding more localised evidence, and ISO 13485 defining global QMS standards, managing global compliance can feel like chasing four moving targets—while blindfolded. But there’s […]
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, […]
