2 min read
From Reactive to Predictive: The Unseen Architecture of Modern Risk Management
How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring
2 min read
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...
7 min read
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...
3 min read
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...
1 min read
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...
5 min read
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...
6 min read
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...
1 min read
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...