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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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  Medical Device Design for Testability

  Medical Device Design for Testability during development explores the pros and cons of its application throughout the entire design process 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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  3 “P’s” of Biomedical Product Development Pitfalls

  Three common elements can be observed in biomedical product development projects that are doomed to failure. They are the Three “P’s” – Platform, Point of Care, and Program Manager.

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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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  4 Regulatory Trends to Watch In 2024

  Overview of 2024 Regulatory trends include QMSR, LDTs, FDA guidances, and timelines in the EU for MDR and IVDR.

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  5 Key Points in FDA’s Real-World Evidence Draft Guidance

  FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.

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  Modular Rapid Prototyping for Point of Care Diagnostics

  How a ready-made modular proof of concept system for rapid prototyping Point of Care Diagnostics can expedite and de-risk product development.

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