Genesys Electronics Design is presenting "Medtech Development: Essential Insights" the Device Development model required for medical device development. This session will cover System design principles from user needs to validation as well the necessary steps to follow to enable design controls early and comply with necessary standards including: 

· QMS for Medical Devices (ISO 13485) 

· Medical Device Equipment Safety and essential performance (IEC 60601-1) 

· Software Lifecycle Processes (IEC 62304) 

· Other relevant standards.