1 of 1 IEC 62304 Jobs in East Anglia

early concept through product release Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.Act as the firmware compliance leader, guiding the team on requirements management, traceability, risk control implementation, verification strategy, and evidence … products that have reached clinical, commercial, or regulatory submission stages Demonstrated experience working within an ISO 13485certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software Strong embedded programming skills in C and experience ...