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  Medical Device Optical Breadboard Prototype Tips

  Tips for building a medical device optical breadboard prototype. When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting.

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  14 Ways to Increase Medical Device Speed to Market

  Speed to market is a crucial part of medical device success. Experts draw upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

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  Commercializing Medical Devices with Optics

  Engineers, regulatory, manufacturing and optics experts share their experiences and lessons learned commercializing hundreds of medical devices with optics components and interacting with optics engineers.

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  Bio Break: Target Product Profile

  Whether you’re in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It’s packed with practical advice and expert insights to set you on the path to success.

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  The Value of SBOMs and SBOM Analysis

  SBOM Analysis and Value covers the FDA “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance, role of Software Bills of Materials (SBOMs), and how to create them.

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  Creating a Medical Device Bootscreen for QNX

  QNX Medical Device Bootscreen tips for the popular micro-kernel OS designed for embedded systems and safety critical hardware.

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  FDA Guidance on Medical Device Cybersecurity Overview

  2024 FDA guidance on medical device cybersecurity covering risk management, design controls and software validation is explained in this article. Cybersecurity, Risk Management, Secure Product Development Framework (SPDF) are also covered.

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  Developing Class C Firmware for Medical Devices

  How to develop Class C Firmware for medical devices and implement Segregation in compliance with the IEC 62304 Standard.

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  Using Language Models (AI) In Medical Devices Responsibly

  Risks, potential roles, and tips for using Large Language Models (LLM) or (AI) in medical devices effectively and responsibly. Role of AI in medical devices: In the medical field, generative language models, colloquially known as “AI” or “LLM” must be used responsibly to enhance the skills of clinicians or improve patient experience without exposing either to increased risk.

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