Oscar He is a Senior Advisor and certified auditor with extensive experience supporting medical device and health software companies across the full product lifecycle.
He works with quality management systems, audits, technical documentation, and regulatory interactions, translating complex requirements into practical, business‑ready solutions. Oscar holds an MSc in Medical Biotechnology from KTH Royal Institute of Technology. He serves on the Board of MEDEA and is a member of the SIS Technical Committee 355, bringing current industry and standardization perspectives into his hands‑on, experience‑based training.