ISO 13485: Comprehensive Overview of the Medical Device Quality Management Standard
ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. It specifies the…
Healthcare
Using SysML and MBSE for Better Compliance in Medical Device Development: How MBSE Tools Can Ensure ISO 13485 Compliance
The development of medical devices requires rigorous compliance with safety and regulatory standards such as ISO 13485, which outlines requirements…