CS-Tran

CS-Tran is a Norway-based regulatory and quality consultancy for medical device companies. It supports EU MDR technical documentation, clinical evaluation reports, literature reviews, post-market surveillance and CE-marking work. Its US services include FDA 510(k) dossier preparation and post-submission support. The practice also provides ISO 13485 quality-system assistance, audits, risk management, PRRC services and device-registration support across several international markets.