Leave the "CE" mark certification for medical devices for the European market to us!
We provide "CE mark" certification services that declare compliance with all safety, health, and environmental protection requirements specified in 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 requests. 【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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【Service Contents】 ■Regular Review ■Renewal Review ■Unannounced Audit ■Other Services ・Expedited Review ・Regulatory Pathway Review (RPR) *For more details, please download the PDF or feel free to contact us.
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【Purpose】 ■ Medical devices for the European market *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.