The Critical Link Between Design Verification & Risk Management in ISO 13485
In the world of medical device development, design verification and risk management are inseparable pillars of product safety. While design verification proves the device meets its design requirements, risk management ensures that it performs safely under all intended conditions— without introducing new hazards to patients or users. Under ISO 13485 and ISO 14971, manufacturers must […]
CDSCO’s 2025 Draft Guidance: Regulating Medical Device Software in India
The Central Drugs Standard Control Organisation (CDSCO) has released extensive draft guidance for medical device software under the Medical Devices Rules (MDR), 2017. This move aims to harmonise India’s device-software oversight with global standards, bringing clarity to classification, licensing, documentation, and post-market surveillance. Defining Medical Device Software Software is a medical device if it serves […]
Why Design Verification Is the Backbone of Medical Device Compliance
Introduction Before a medical device ever touches a patient’s life, its safety, accuracy, and performance must be proven beyond question. This critical assurance begins not at the manufacturing line, but within the design verification process — the true backbone of regulatory compliance. Far from being a bureaucratic hurdle, design verification is where engineering precision meets […]
Balancing Speed and Safety: How the FDA’s 2025 IVD Guidance Shapes Future Outbreak Responses
Introduction In September 2025, the U.S. Food and Drug Administration (FDA) finalised guidance detailing how it will authorise in vitro diagnostic (IVD) tests under emergency conditions. This move responds to longstanding calls for clarity in public health emergencies. The guidance aims to strike a balance—ensuring that rapid diagnostic tools are available when needed, while still […]
Global Regulatory Update: IMDRF Strengthens International Cooperation in Medical Device Regulation
Overview The International Medical Device Regulators Forum (IMDRF) continues its mission to harmonise and strengthen global medical device regulations. By accelerating international regulatory convergence, IMDRF aims to build a more efficient, effective, and responsive global regulatory model—one that keeps pace with rapid technological innovation while ensuring public health and safety. 28th IMDRF Management Committee Meeting […]
CDSCO’s New Provision on Subsequent Importers: What Medical Device Companies Need to Know
Introduction The Central Drugs Standard Control Organisation (CDSCO) has recently updated its regulatory framework to streamline the role of subsequent importers of medical devices in India. This move directly impacts manufacturers, authorized representatives, and distributors who rely on multiple import partners. At Bioexcel, we’ve broken down what this new provision means, why it matters, and […]
MDCG 2025: The New Era of Vigilance & Trend Reporting for Medical Devices
Introduction The European regulatory landscape is evolving once again. With the upcoming MDCG 2025 guidance, medical device manufacturers face a major shift in how post-market vigilance is managed. Trend reporting — once seen as optional or secondary — is now a mandatory requirement. This change will fundamentally reshape how manufacturers track, analyse, and report device […]
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 […]
