ドキュメントセイフティ Company Profile

Business Activities

■Relationship between MDR Annex and Translated Documents 　・IFU (MDR Annex I) 　・Risk Management Documents (MDR Annex I) 　・Technical Documentation (MDR Annex II) 　・Technical Documentation on Clinical Evaluation (MDR Annex XIV) 　・Technical Documentation on Post-Market Surveillance (MDR Annex III) 　・Quality Management System (QMS) Documents (MDR Annex IX) 　・Other Verification Documents from Competent Authorities (CA) and Notified Bodies (NB) (Various MDR Annexes) ■Translation and Native Check Support 　・Translation covering harmonized standards 　・Translation utilizing your existing documents (software assets) 　・Translation into English and other official languages of European countries 　・Native checks in each language ■Editing, Writing, and Compliance Support 　・Support for creating IFU (Instruction for Use) 　・Support for compliance of IFU with harmonized standards ■DTP Editing and Technical Illustration Production 　・DTP editing in various languages (Word/Excel/InDesign/FrameMaker/Illustrator, etc.) 　・Creation of various technical illustrations

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