F&R Solutions

F&R Solutions is a Montreal-based practice founded and led by principal consultant Rama Almaleh. It helps medical device companies build quality systems and audit-ready documentation for ISO 13485, MDSAP and FDA QMSR requirements. Its FDA-related services include 510(k) documentation support, mock audits, risk management, software and SaMD files, and UDI, GUDID and FURLS setup.