MIT SDM: Medical Device Development - Architecting Trust
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This MIT IAP short-course will dive into medical device product development in combination with quality management and regulatory strategy. Layered into this will be MIT SDM’s systems thinking approach applied to engineering, design, and strategic decision making.
We will cover the nuts and bolts of implementing a quality management system and explore how it’s requirements, along with those posed by regulatory bodies and other product safety standards, impact not just the development of a medical device, but the operations of the entire company.
Day 1: Architecting Trust - Stakeholder Value Mapping, FDA Pathways, and Product Lifecycle
Day 2: A Case for Quality - Quality Management (ISO 13485) and Risk Management (ISO 14971)
Day 3: The Human Element - Patient, User, and Product Safety (IEC 62366 and 60601-1)
Day 4: Going Digital - Software as a Medical Device (IEC 62304), Data Privacy, and AI (FDA GMLP)