Health Sciences and Medical Devices Consultant
Discover how AI is transforming Quality and Regulatory Affairs in this 3-day online training. Learn from industry expert James Pink how to apply AI to regulatory intelligence, submissions, QMS, and auditing while meeting FDA, EU, and ISO 42001 requirements.
Combination Products: Quality & Regulatory Requirements
AI-enabled medical devices are now being assessed through multiple overlapping lenses: medical device regulations (EU MDR/IVDR, FDA frameworks), emerging horizontal regulation (EU AI Act), and rapidly evolving expectations for clinical safety, lifecycle control, and transparency. This 3-day live online training focuses on what teams need to implement to build, document, and maintain AI systems that can withstand review — from defining intended purpose and classification, through design control and risk management, to QMS integration and post-market oversight. The sessions are designed for cross-functional alignment: regulatory, QA, clinical, design, and technical stakeholders leave with a shared view of terminology, responsibilities, and evidence expectations.
Join medical devices online course with certificate and gain practical tools for process risk assessment during scale up of medical devices.
Apply user-centered design principles to the development of combination products. The agenda covers all stages of documentation, risk management, design control and regulatory submissions.
