Clinical Investigation of Software as Medical Devices (SaMD) – A Focus on AI-Powered Solutions
Course Description: In the rapidly evolving landscape of digital health, software has taken center stage in medical device innovation, particularly those harnessing the power of Artificial Intelligence (AI). “Clinical Investigation of Software as Medical Devices (SaMD) – A Focus on AI-Powered Solutions” is a cutting-edge course designed for professionals who aspire to master the regulatory […]
Introduction to EU CE Marking for Medical Devices
Navigating Compliance and Technical Documentation Welcome to “Navigating Compliance and Technical Documentation,” a detailed and practical course aimed at demystifying the process of achieving the respected EU CE Marking for medical devices. As the medical field advances rapidly, the importance of ensuring the safety and efficacy of new devices cannot be overstated. This course is […]
Introduction to ISO14155 and Clinical Investigations for Medical Devices
Exploring ISO 14155:2020 – Navigating Clinical Investigations for Medical Devices Welcome to a comprehensive course designed to unravel the intricacies of ISO 14155:2020—an international standard that forms the bedrock of good clinical practices in the realm of medical devices. As innovation in healthcare surges forward, ensuring the safety and performance of medical devices is of […]
Mastering Clinical and Regulatory Documentation: Crafting a Path to Success
Welcome to a comprehensive suite of courses meticulously designed to empower you with the expertise to prepare unparalleled clinical and regulatory documentation. In a landscape where precision is paramount, these courses spotlight the art of crafting best-in-class documentation that lays the foundation for clinical development programs, medical device approvals, and successful marketing endeavors. Through these […]
