How to Justify Sample Size in Medical Device Trials
Introduction Determining the right sample size is a critical step in designing any clinical trial, and medical device studies are no exception. How many patients do we need? is not just a statistical question – it’s a regulatory and ethical one as well. Regulators expect sponsors to justify their sample size with a solid scientific […]
Human Factors in Clinical Trials: Bridging Usability & Safety
Introduction When testing a new medical device, ensuring it is not only effective but also usable and safe in the hands of real-world users is paramount. Human factors (HF) engineering – sometimes called usability engineering – focuses on how people interact with devices, aiming to minimise use errors and enhance user experience. Bridging human factors […]
ISO 14155:2020 Demystified — Designing Compliant Clinical Investigations
Introduction Within the field of medical device trials, ISO 14155:2020 serves as the definitive guideline for Good Clinical Practice (GCP). This international standard, titled “Clinical investigation of medical devices for human subjects – GCP”, demystifies what it takes to design and conduct device trials that meet ethical and scientific quality benchmarks. For sponsors and Clinical […]
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 […]
