ISO 13485:2016 certified.

MDSAP ISO 13485:2016 certified.

Anacapa Technologies has implemented and maintains a Quality Management System that fulfills the requirements of ISO 13485:2016 under MDSAP. NSAI, our Registrar/AO carries out ongoing assessments and issues our certificates of registration. Our products meet the requirements for a comprehensive quality management system for the design and manufacture of medical devices.