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  FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions

  Summary of nine-step process for developing and assessing the credibility of CM&S for regulatory submissions in the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions (17th November 2023)”.

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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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  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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  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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  Medical Device Post-Market Surveillance Enhances Safety

  Medical device post-market surveillance (PMS) is important to identify and address potential safety issues and improving device performance. Article covers regulatory landscape, challenges, innovations and collaborative efforts.

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

  Understanding similarities and differences between Medical Device 510(k) and CE Marking regulatory pathways helps harmonize overall regulatory strategy.

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  ESG Medical Device Impact

  Environmental, Social and Governance (ESG) Medical Device Impact tips to ensure that your products fulfill compliance obligations. Major buyers request ESG reporting from suppliers as new and revised regulations require supply chain attention.

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