The Risks of Misclassification in Medical Devices: Why Getting It Right Matters
Correct classification is the foundation of medical device compliance. It determines the regulatory pathway, the level of scrutiny, the depth of technical documentation required, and the evidence needed to demonstrate safety and performance. Both the MHRA and EU authorities are ramping up oversight and identifying more products on the market that do not meet the […]
FDA Draft Guidance: Quality Management System Information for Premarket Submissions (QMSR 2026)
The FDA has released a draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews”, outlining how manufacturers must demonstrate their Quality Management System (QMS) compliance under the upcoming Quality Management System Regulation (QMSR). The QMSR, set to take effect on 2 February 2026, represents one of the most significant changes to U.S. […]
International Recognition of Medical Devices: MHRA’s Policy Explained
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a landmark policy proposal that will reshape how medical devices gain market access in Great Britain. This Statement of Policy Intent on International Recognition, first published in February 2025 and updated in October 2025, sets out how the MHRA plans to recognise medical device […]
Computer Software Assurance: Understanding the FDA’s New Guidance
The FDA’s Computer Software Assurance (CSA) guidance marks a significant shift in how medical device manufacturers validate software used in production and quality systems. Rather than treating every line of code with equal scrutiny, the new approach allows manufacturers to prioritise assurance activities based on risk, reducing unnecessary documentation while improving focus on systems that […]
Implementing ISO 13485: Building a Software-Focused Quality Management System for Medical Devices
Developing a medical-device software product demands more than technical innovation. It requires a robust, traceable, and auditable Quality Management System (QMS) that satisfies ISO 13485:2016. This international standard defines the framework for designing, manufacturing, and maintaining safe and effective medical devices. For software developers, it bridges the gap between agile engineering and regulatory rigour, ensuring […]
Clinical Evidence for Medical Devices: How to Perform an Effective Literature Search
Demonstrating robust clinical evidence is essential for EU MDR and IVDR compliance. For most manufacturers, this begins with a structured and reproducible literature search, the cornerstone of a clinical evaluation. An effective literature search identifies existing safety and performance data, benchmarks the state of the art, and supports claims about device equivalence or similarity. Poorly […]