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As artificial intelligence continues to revolutionize medical device development, the FDA’s evolving regulatory framework presents both opportunities and challenges for manufacturers. The recently released guidance on AI/ML-enabled medical devices...
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The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers...
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The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning...
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When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving...
6 min read
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
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Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic...
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Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success....
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Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization. Below are a few...
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Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
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How do regulatory requirements within the medical device industry impact a database build? What are the important items to be aware of? In this blog,...
