CE技术文件2.docVIP

Table of Contents No. Document name Page No. Page number 1 Introduction of Manufacturer 2 1 2 Introduction of Product 3-6 4 3 Instruction for User 7 1 4 Applicable Standards 8 1 5 Label and Language 11-16 6 6 EC Declaration of Conformity 17 1 7 Essential Requirement Checklist 18 1 8 Risk Analysis Report 19 1 9 Test Report 20 1 10 Production Flow Chart 21 1 11 Attachment List and Attachments 22 1 Introduction of Manufacturer Introduction of the Manufacturer Our?company?Risen?started?medical?product?business?in?2006,?professional?in?manufacture?medical?orthopedic?products?(knee?