Home testing kits may seem like consumer products with sleek packaging, simple instructions, and sold online or in pharmacies. However, under EU law, they are some of the most tightly regulated diagnostic devices on the market.
Home Testing Kits Regulations: IVDR Compliance Guide Read More »
IVDR has fundamentally reshaped the regulatory landscape for in vitro diagnostic devices, and, yes, it’s still catching many manufacturers off guard years after its implementation.
IVD Consultancy: Practical IVDR Compliance Strategies Read More »
Even the most sophisticated medical device companies can stumble when their quality management system (QMS) fails. When that happens, it’s rarely a minor inconvenience – it is more often a chain reaction of recalls, warning letters, certificate suspensions, and huge remediation bills.
Top 5 Quality Management System Failures to Prevent Read More »
Confused about the difference between CE Marking and UKCA marking? This guide explains the key regulatory differences, where each marking applies, the transition arrangements through to 2030, and what medical device manufacturers need to do to access the EU and Great Britain markets.
CE Marking vs UKCA: What’s the Difference for Medical Device Manufacturers? Read More »
The newly revised ISO 10993-1:2025 has quietly done something big: it’s turned biological evaluation from a “tick-the-box biocompatibility test list” into a fully integrated risk narrative that regulators now expect to hold together scientifically, from chemistry through to clinical data.
ISO 10993-1:2025 Explained: What’s Changed and What Manufacturers Need to Do Read More »
After years of “coming soon”, the EU has finally put a fixed date on reality: the first EUDAMED mandatory modules must be used from 28 May 2026.
EUDAMED Mandatory from May 2026: What You Need to Know Read More »
Software is now the beating heart of modern medical devices. Whether you’re building a connected inhaler, an AI-driven diagnostic tool, or an embedded control system inside a Class III device, regulators expect one thing above all: evidence that your software is safe, controlled, validated, and maintained throughout its entire lifecycle.
IEC 62304 Explained: Medical Device Software Development Guide Read More »
A compliant Quality Management System (QMS) forms the foundation of every successful medical device manufacturer. While ISO 13485 contains numerous documentation requirements, several core documents underpin regulatory compliance, product quality and continual improvement. In this guide, we explain the seven essential QMS documents every manufacturer should establish and how they support compliance with ISO 13485, the EU MDR and the IVDR.
7 Core Quality Management System (QMS) Documents Every Medical Device Manufacturer Needs Read More »
Clinical Evaluation remains one of the most heavily scrutinised aspects of EU MDR conformity assessment. Recent Medical Device Coordination Group (MDCG) guidance has strengthened expectations for Clinical Evaluation Reports (CERs), clinical evidence, equivalence, Post-Market Clinical Follow-up (PMCF) and lifecycle documentation. This guide explains the latest 2025 MDCG developments and the practical steps manufacturers should take to remain compliant.
Clinical Evaluation Under the EU MDR: 2025 MDCG Updates Read More »
ISO 14971 and ISO 13485 are closely linked standards that work together to ensure medical devices remain safe, effective and compliant throughout their lifecycle. While ISO 14971 provides the framework for identifying, evaluating and controlling risks, ISO 13485 establishes the Quality Management System (QMS) needed to implement those controls consistently across design, manufacturing, supplier management, Post-Market Surveillance and continual improvement. Understanding how these standards complement one another is essential for achieving MDR, IVDR and UK MDR compliance.
ISO 14971 and ISO 13485: How Risk Management and Quality Work Together Read More »
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