FEATURED EDITORIAL
A Better Interpretation Of POH In ISO 24971
Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.
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Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.
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One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.
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In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.
INDUSTRY INSIGHTS
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Discover How Our Polyurethanes Can Enhance Your Medical Device Designs
Medureon™ is a family of medical-grade polyurethanes engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.
Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.
Capacitor selection for LC tank circuits depends on temperature stability, ESR, and construction; Class I dielectrics offer low loss and high stability, while Class II allow higher capacitance.
Resonant circuits, like LC tank circuits, store and exchange energy between capacitors and inductors. A spring-and-mass analogy helps visualize oscillation and frequency-selective behavior.
Class E RF generators use high-efficiency switching amplifiers with critical capacitors for waveform shaping, impedance matching, and energy storage across telecommunications, medical, industrial, and research applications.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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