Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple animation performs two purposes. One is simply that it looks good, plus companies can personalize and add their branding to it. But the second reason is arguably more important; it lets […] The post Creating a Medical Device Bootscreen for QNX appeared first on StarFish Medical ..read more

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity into the quality system management and premarket submission process for medical devices. It covers risk management, design controls, software validation, and other elements to ensure the safety, […] The post Overview of the New FDA Guidance on Cybersecurity appeared first on StarFish Medical ..read more

You have done your Software Risk Analysis and have identified your Firmware to be of Software Safety Class C. What next? There are 3 points of the IEC 62304 Standard specific to the design of Class C Medical Device Firmware: Segregation, Detailed Design for Interfaces, Additional Software Unit Acceptance Criteria. IEC 62304 standardizes the Software Life […] The post Developing Class C Firmware for Medical Devices appeared first on StarFish Medical ..read more

Generative language models, colloquially known as “AI”, have been making waves across many different sectors in a wide range of roles, ranging from customer support chatbots to programming assistants, and even to a new wave of web search tools. The invasion of so many (large language model) LLM-based products has also sparked furious debate about […] The post Using Language Models (AI) Responsibly In Medical Devices appeared first on StarFish Medical ..read more

Understanding Post-Market Surveillance: In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase, where vigilant surveillance becomes paramount. This blog delves into the significance of post-market surveillance (PMS) for medical devices, exploring its importance, challenges, and potential improvements. PMS is the […] The post How Post-Market Surveillance Enhances Medical Device Safety appeared first on StarFish Medical ..read more

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects of an overall regulatory strategy. Editor’s Note: This article updates and replaces Vincent Crabtree’s 2014 blog on 510(k) and CE Marking (Pt 1 and Pt 2). FDA has a clear definition […] The post Similarities and Differences between Medical Device 510(k) and CE Marking appeared first on StarFish Medical ..read more

This year’s International Women’s day theme is ‘Inspire Inclusion’. In this blog I’ll share statistics around women in Science, Technology, Engineering and Mathematics (STEM) and the inspiration I’ve gained from inclusion improvements during my career. I was brought up as a daughter of an engineer, often taken into work when school was out. So, from […] The post Inspiring Inclusion – Women in STEM appeared first on StarFish Medical ..read more

The gender data gap of high-quality, gender-specific data represents a critical challenge in healthcare, particularly in the development and efficacy of medical devices for women. Drawing upon Caroline Criado Perez’s insightful work, “Invisible Women: Data Bias in a World Designed for Men,” and the commentary “Medical Devices, Invisible Women, Harmful Consequences,” by Phillips et al. […] The post Gender Equity in Medical Devices: Bridging the Data Gap appeared first on StarFish Medical ..read more

FDA Quality Management System Regulation (QMSR) In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly used ISO 13485 Medical devices – Quality management systems[1] – Requirements for regulatory purposes. This had been long awaited and was rumoured to be coming for many years prior to this point. As […] The post 4 Regulatory Trends to Watch In 2024 appeared first on StarFish Medical ..read more

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” issued by the FDA elaborates on how real-world evidence (RWE) can be effectively used in regulatory decision-making for medical devices. […] The post 5 Key Points in FDA’s Real-World Evidence Draft Guidance appeared first on StarFish Medical ..read more