REGULATION

COMPLIANCE

As a professional contract manufacturer of medical device, Delta Asia has established a QMS which in compliance with international regulation requirements and provides the services that support customer regulatory compliance from device development to commercialization and potential design change in entire product life-cycle, e.g. 510 (k) submission, PMA filing, technical files for CE-marking and post-market activities.

Delta Asia provides tailor-made prototype, engineering and clinical devices for customers’ need under the provision of design controls regulations. While customers undertake the application of regulatory approval to market their medical device, we support customers the necessary documents and records for submission filing. After the marketing approval or clearance, Delta Asia adheres to design transfer documents and DMRs to produce and supply product to customer. Subsequently, we support customer on complaint handling regarding the investigation of manufacturing activities and risk assessment of the complaint.