AI in Clinical Trials for Medical Devices: What’s New in 2025
Clinical trials for medical devices are undergoing a transformation thanks to artificial intelligence (AI). From designing smarter studies to speeding up patient enrolment and crunching vast datasets, AI is helping device makers and researchers conduct trials more efficiently and adaptively. This post explores how AI is being applied in trial design optimisation, patient recruitment, data […]
Common Clinical Trial Pitfalls That Delay CE Marking—and How to Avoid Them
Introduction: Achieving CE Marking for a medical device under the EU MDR is challenging even when everything goes right. Unfortunately, there are common pitfalls in the clinical trial and evidence development process that can derail or delay your CE Mark submission. Many manufacturers have faced questions, requests for additional data, or outright refusals from notified […]
From Idea to Approval: What Sponsors Must Know Before Their First Trial
Introduction: The journey from a bright medical device idea to an approved product on the market is exciting – but it can be daunting for first-time sponsors. Before launching your first clinical trial, there are critical things you need to know and prepare. A clinical trial is not just an experiment; it’s a highly regulated […]
Navigating IVDR & WHO TSS-1 Compliance for In Vitro Diagnostic Devices
Your Complete Guide to EU Market Access & Global Quality Standards In Vitro Diagnostic Medical Devices (IVDs) are essential tools in modern healthcare — enabling disease detection, treatment monitoring, and population screening. Under Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, or IVDR), IVDs are defined as devices intended by the manufacturer to be […]
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 […]
