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What are the benefits of obtaining ISO 13485 medical device standard certification?

• Compliance with regulatory requirements and customer expectations
• Improve processes across the enterprise organization
• Verification increases access to more global markets
• Prove that you produce safer and more effective medical equipment
• Improve efficiency, reduce costs and monitor supply chain performance

Focus on

1. Clearer definition of medical device proper nouns
2. Integrate global regulatory requirements
3. Integrate risk management and risk-based decision making throughout the quality management system
4. Propose a clearer structure for the medical device file
5. Put forward clearer requirements for verification, validation and design control
6. Strengthen the control of the supply chain
7. Strengthening the focus on feedback mechanisms
8. Proposed clearer software validation requirements for various software applications
9. Key vocabulary highlighted in the new edition:
10. Regulatory Regulation Validation Confirm Sterile Software
11. Proportionate to the risk associated with the medical device
12. Architecture: No change, maintain 8 chapters with ISO13485:2003
13. Buffer period: 3 years, until February 2019 Now Must the new Rev after 2019 March