Russell Haley

Overview of the New FDA Guidance on Cybersecurity

FDA Guidance Medical Device CybersecurityCybersecurity 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, effectiveness, and security of medical devices in the face of potential cyber threats.

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Bertram Hildebrand

Developing Class C Firmware for Medical Devices

Medical Devices Developing Class C FirmwareYou 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 Cycle Processes for Medical Device Software providing a common framework for software development and maintenance processes and activities. Written as a process standard, it tells what to do, but not how to do it. This blog shares the StarFish Medical approach to Segregation.

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Thor Tronrud

Using Language Models (AI) Responsibly In Medical Devices

Using AI In Medical Devices
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 their reliability, particularly in high-risk applications. In the medical field, potentially gigantic opportunity is balanced against life and death stakes. This new technology must be used responsibly in a way that can enhance the skills of the clinicians or improve the patient experience without exposing either to increased risk.

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James Sease

Design for Testability

Medical Device Design for TestabilityMany different aspects must be considered when designing a medical device. This is particularly true with more complex devices that rely on internal computers to support their function. Every device must be safe, effective, affordable, easy to use, etc. But one aspect that can be overlooked in favor of the shinier factors is testability.
Design for Testability refers to keeping testability as a major design concern throughout the whole design process, ensuring that all parts of the product can be both manipulated and monitored allowing for thorough testing.

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Palash Jha

How Post-Market Surveillance Enhances Medical Device Safety

Post-Market Surveillance Medical DevicesUnderstanding 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.

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Dhruvitha Krishna

Similarities and Differences between Medical Device 510(k) and CE Marking

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).

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Sean Mitchell

ESG Medical Device Impact

ESG Medical Device ImpactAs major buyers continue to request Environmental, Social and Governance (ESG) reporting from suppliers, there will continue to be new and revised regulations requiring supply chain attention. Jurisdictions all over the world are increasingly enacting regulations aimed at curtailing the use, import and/or export of certain substances in response to political, environmental and social responsibility concerns. These regulations have far-reaching implications for designers, manufacturers and importers of complex Medical Devices and related equipment.

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Alexandra Reid

Gender Equity in Medical Devices: Bridging the Data Gap

Gender Equity Medical DevicesThe 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. this blog outlines the gender data gap’s implications on women’s health and lists strategic measures for its integration into medical device regulatory frameworks and design processes.

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Helen Simons

4 Regulatory Trends to Watch In 2024

2024 Regulatory Trends

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 many manufacturers of medical devices and in vitro diagnostics (IVD) were already complying with this standard due to other regulation requirements, it made sense for the FDA to align with this industry ISO standard.

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Alexandra Reid

5 Key Points in FDA’s Real-World Evidence Draft Guidance

FDA Real-World Evidence Draft GuidanceThe 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.

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Astero StarFish

21 Interview Questions that Work (and Why)

21 Interview Questions that Work
It’s job-hunting season! This blog shares favorite questions and techniques (with the reasoning behind these questions) that our employees have used or encountered for a variety of roles in medical device development. An interesting mix of classics and new twists, we hope they provide inspiration for future interviews and insights into StarFish culture. 

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