ECNE Senior Advisor
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
A Chartered Engineer and RAQA professional with extensive experience in MedTech design, quality and regulatory requirements across US, European and Asian markets.
A trained Six Sigma Black Belt, he began his career designing surgical instruments and electromedical devices for orthopaedic, microvascular and ophthalmic applications.
He has supported clinical trials and premarket approvals, managed EU MDR CE marking, FDA 510(k) submissions and PMAs, and led FDA inspections and notified body audits. His approach focuses on pragmatic compliance and analytics aligned with business needs.
Be the first to know
Sign up to our mailing list to receive regular updates on medical writing and clinical research topics.