RCF Consulting

RCF Consulting is Rebecca Funston's independent senior regulatory, quality and clinical practice in Belfast. It supports medical device companies with EU MDR technical files, classification, risk management and regulatory roadmaps. US work includes FDA 510(k), De Novo and premarket submission support. Clinical services cover evidence-generation strategy, clinical evaluation plans and reports, investigation documents, PMCF and post-market surveillance, alongside ISO 13485 quality-system implementation and audit preparation.