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From Reactive to Predictive: The Unseen Architecture of Modern Risk Management
How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring
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Medical Device Innovation: A Doctor’s Journey to Transforming Respiratory Care
Maria Artunduaga, MD, MPH, MTM Founder and CEO of Samay In This Podcast: How and why Dr. Artunduaga created her company The challenges she faced...
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AI Medical Devices: Answering Your Burning Questions
As artificial intelligence continues to revolutionize medical device development, the FDA’s evolving regulatory framework presents both opportunities...
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AI Medical Devices: Key Considerations for Development and Documentation
The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers...
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Advanced CT Imaging in Preclinical Research: Pioneering Tomorrow’s Cardiovascular Innovations Today
The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning...
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Rescue Studies: Salvaging Clinical Trials Through Expert Data Management
When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving...
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Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
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Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions
Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic...
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Testing Medical Devices with Artificial Anatomy Models
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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Five Questions to Ask When Evaluating a Preclinical CRO
Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization. Below are a few...