ISO 13485 medical device certification

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Following are key requirements of ISO 13485 medical devices quality system certifications

1. Preparation of quality manual and quality procedures
2. preparation of quality policy and quality objectives
3. Appointment of specific responsibilities as per national / international legal rules
4. review of legal requirements
5. Providing clean ,hygenic & product – production adequate work environment
6. Reverting on advisory notices
7. Clinical evaluations of product under development
8. control of product installation and services
9. validation of softwares
10. validation of sterile medical devices
11. Maintaining specific identification and traceability
12. Risk management as per relevant risk management standard such as ISO 14971
13. other quality management system requirements as applicable

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