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 […]
Predicate Puzzle: Finding the Right Device for a 510(k) Submission
Expanding into the U.S. market is a milestone for many MedTech innovators, but it brings with it a complex regulatory challenge. For most medical devices, the most practical route to U.S. market entry is the FDA 510(k) submission a pathway that relies on demonstrating substantial equivalence to an existing, legally marketed predicate device. Selecting the […]
AI in Medical Devices: Post-Market Surveillance and FDA Guidance
Artificial intelligence (AI) is transforming medical technology. Yet, unlike static hardware or conventional software, AI- medical devices (AIMD) evolve. Their algorithms can drift, degrade, or even introduce new risks once deployed in real-world clinical environments. For founders and product leads, this presents a challenge: how do you maintain regulatory compliance while allowing your AI model […]
IEC 62304 Compliance Checklist for Medical Device Software Teams
As medical devices become more software driven, it’s crucial that we get the safety and reliability right. That’s where IEC 62304 comes into play. In this blog, I’ll break down what IEC 62304 actually is, why it matters for anyone developing medical device software, and who should be paying attention. I’ve also pulled together a […]