ments Checklist ? 3. Risk Analysis ? 4. Drawings, Design,- Product - Specifications ? Chemical, physical and biological tests ? 5.1 In Vitro Testing - Preclinical Studies ? 5.2 patibility Tests ? 5.3 Biostability Tests ? 5.4 Microbiological Safety, Animal origin tissue ? 5.5 Coated Medical Devices ? 6. Clinical Data ? 7. Package Qualification and Shelf life ? 8. Labels - Instructions for use - patient informations - advertising materials ? 9. Manufacturing ? 10.Sterilization ? 11.Conclusion ? 12.Declaration of Conformity (Draft) 国外注册要求(CE) 适用范围 Scope 适用于本公司设计和生产的所有医疗器械, 包括新产品研发和现有产品的改进等,包括: 软件开发软件升级 Apply to all medical devices applicable to which will be design and manufactured by Medical Zenith, including new products or enhancement to the existing product. 职责 Responsibility
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