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By Marcelo Trevino, independent expert | This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices. | |
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By Summer Xia, associate director of medical devices, Freyr Solutions | Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in China. | |
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By Ammarah Sulaiman, biomedical engineer | Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks. | |
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| The Ultimate Guide To Biological Indicators | Article | Mesa Laboratories | Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device manufacturing, as well as how choosing the right one ensures safety. |
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| Turning PFAS Challenges Into Opportunities | Article | Battelle | Medical device makers face growing global pressure to eliminate PFAS. Embracing circular design and innovation offers a path to compliance, sustainability, and supply chain resilience. |
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| The 5 Ws Of A Human Factors Strategy | White Paper | Eurofins | A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes. |
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