Quality & Regulatory Compliance
- Ensure all embedded software is developed in compliance
with:
- FDA 21 CFR Part 820 / Part 11
- ISO 13485
- IEC 62304 (Medical Device Software Lifecycle Processes)
- ECSS-E-ST-40C(European Space Agency Software Lifecycle Processes)
- ISO 14971 (Risk Management)
- Oversee traceability from requirements to implementation and validation.
- Support internal and external audits (e.g., TRR, VeRR, ISO, FDA, Notified Bodies).