Triune Technologies

Triune Technologies (Triune Tech) is a technology focused and innovation driven company principally involved in providing expert technical advice and consultancy in medical and healthcare industries worldwide. Areas of active services include regulatory affairs (submission and compliance) - CE Mark, own brand labeling, FDA 510(k) & PMA - Submissions, product design and development, clinical evaluation report, quality management systems - ISO 9001, ISO 13485, FDA QSR, 21 CFR 820 (for medical device - regulatory compliance), environmental management system, ISO 14001, risk management (ISO 31000, ISO 14971), project management (ISO 21500), labeling and instructions for use (IFU) / operating manuals preparations.