Transform Regulatory Challenges into Strategic Advantages: Medical Device Software Standards
Join regulatory expert Ginny Kwan Gattinger, Partner at SoftwareCPR, for an insightful webinar that turns complex medical software standards into practical strategies. In this session, she’ll decode critical frameworks like IEC 62304 and IEC 82304, share proven approaches for successful FDA and global regulatory compliance, and reveal how regulatory, and quality professionals can effectively support and strengthen development teams working on Software as Medical Devices (SaMD). Whether you’re in regulatory affairs, quality assurance, software development, or aspiring to enter these fields, you’ll gain actionable insights to navigate the evolving landscape of medical software compliance with confidence and efficiency while ensuring the highest standards of quality and patient safety.