We are a registered certification body that provides ISO 13485 certification services!
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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【Service Contents】 ■Periodic Audit (Surveillance) ■Renewal Audit ■Supplier Audit ■Other Services ・Pre-Guidance ・Combined Audit with Other Quality Management Systems *For more details, please download the PDF or feel free to contact us.
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Our company, founded in 1925 as the "German Automobile Inspection Association," is a world-class certification body with a long history. Our experienced professionals ensure even greater safety in important living environments such as transportation, workplaces, and homes. Please feel free to contact us if you have any inquiries.