Certifications & Quality

Global Standards & Quality Assurance

Certified Quality Management Systems

### International Compliance
Fresh Surgical Valley is committed to meeting and exceeding global healthcare regulations. Our manufacturing systems are audited and certified to ensure the highest safety for patients and ease of use for surgeons.

### Key Certifications
– **ISO 13485:2016:** Medical devices — Quality management systems.
– **ISO 9001:2015:** Quality management standards.
– **CE Mark:** Compliance with European Union safety, health, and environmental requirements.
– **FDA Registered:** Meeting United States Food and Drug Administration standards.

### Quality Inspection Workflow
We don’t just inspect the final product; we inspect every stage of the lifecycle.
1. **Material Testing:** Chemical analysis of steel batches.
2. **Dimension Control:** Micrometer-level accuracy checks.
3. **Functionality Test:** Ensuring scissor sharpness and forceps alignment.
4. **Boil Test:** Verifying corrosion resistance and passivity.