Services

Support with FDA 510(k), CE Marking, and ISO pathways. Early risk mapping and documentation to align with global requirements. We help you prepare regulatory submissions with clear technical files and strategic foresight. 

Build and strengthen QMS under ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820. CAPA and usability integration included. We design processes that scale from startups to mature manufacturers. 

Guidance on U.S. reimbursement, APAC entry, and regulatory–commercial alignment to accelerate adoption. Our approach balances compliance with business objectives for faster, safer market entry.