Services by KBD to the customers

Consultation with product development strategy for Medical devices, IVDs and Bio-related products
Consultation with product distribution strategy to the Japanese market
Preparation of Application dossiers, STED and annexed documents
Preparation of Application dossiers for QMS(Manufacturing licenses),
GQP&GVP(Marketing license) and SOP(Operational documents) for these licenses
QMS compliance review application dossiers
Preparation of Answer for addressing queries from PMDA or Third party certification body
Preparation of SOPs documents to obtain ISO13485

Other services to the customers

Marketing assessment & Feasibility Study
Assistance with Japanese distribution & Wear house control
Assistance with QC inspection, Regulatory labeling, Pamphlet planning
Technical translation of Scientific papers, IFU and Package insert

Job Experiences & Performance