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 introduces crucial...
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 facilities in Paris and Atlanta combined with the expertise of our people represent the cornerstone of modern preclinical...
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 valuable research and protecting investments in medical device development. But what exactly constitutes a rescue study,...
AI Medical Devices: Your Comprehensive Guide to Development and Documentation
The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers and developers, the path from concept to commercialization demands meticulous attention to regulatory requirements and...
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 functions (AI-DSF). In 2024-2025, the agency released two crucial guidance documents that reshape the submission process...
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 alignment ensures regulatory equivalence with EU IVD regulations (2017/746 EC, IVDR) while providing manufacturers...
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. Artificial anatomy models for medical device testing offer a practical, cost-effective solution that addresses many...
Five Questions to Ask When Selecting a CRO for Preclinical Studies
Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization Below are a few must-ask questions for medtech companies in the market for a CRO that can perform preclinical studies Are you GLP...
Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
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 agreements between a Private Label Manufacturer (PLM) and an Original Equipment Manufacturer (OEM). Although the IVDD...
Training: ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
Speaker Jérôme Randall, PhD Scientific Affairs Manager Date March 11th & 13th 2025, Online Duration 6 hours | 2 x 9:00 – 12:00 AM US Eastern Standard Time, 2 x 3:00 – 6:00 PM Central Europe Time Virtual A recording will be available to registered participants, in...