DEKRAサーティフィケーション・ジャパン List of Products and Services

We provide "CE mark" certification services that declare compliance with all safety, health, and environmental protection requirements specified by the Medical Device Directive. The CE certificate is valid for three years from the date of issuance, after which renewal of the certificate is required. Please feel free to contact us if you have any inquiries. 【Process to Obtain Certification】 1. Document Review 2. On-site Audit *For more details, please download the PDF or feel free to contact us.

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We provide certification services for the international standard "ISO 13485," which offers guidelines and tools for establishing an effective quality management system for medical devices and services. It is also possible to combine CE certification as an option. The certificate is typically valid for three years from the date of initial issuance. 【Certification Process】 ■ Stage 1: First Stage Audit ■ Stage 2: Second Stage Audit *For more details, please download the PDF or feel free to contact us.

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