Ram Bhandari

I’m a detail-oriented engineering professional with hands-on experience producing regulated technical documentation, risk analyses, and compliance deliverables for Class II medical devices at Philips. I translate complex engineering requirements into clear, standards-mapped outputs—PRDs, URDs, test protocols, DFMEAs, and labeling plans.

I’m comfortable working independently within regulatory frameworks including ISO 14971, IEC 62304, IEC 62366-1, ISO 80601 series, and EU MDR. In my Philips role, I authored and reviewed risk documentation using severity/occurrence/detection scoring and documented mitigations within the Risk Management Matrix (RMM) per ISO 14971.

Across cross-functional teams in Regulatory, Quality, and Engineering, I coordinate design reviews and change control via SAP PLM (DCR, ECR/ECO) and support Quality systems like CAPA using TrackWise. I also strengthen documentation through data analysis in Python/Excel, including reliability and degradation trend insights.