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Medical and Medical Aesthetics & Wellness

Medical and Medical Aesthetics & Wellness

Section 1: Industry Pain Points
• High Safety and Accuracy: Medical equipment is directly related to life safety, requiring guaranteed signal acquisition accuracy and low noise.
• Strict Regulatory Compliance: Must comply with multiple medical regulations such as ISO13485, FDA, and CE, with high compliance thresholds.
• Long-Term Stability: Must maintain an extremely low failure rate throughout the equipment's lifespan (5-10 years) to avoid downtime risks.

Section 2, Our Industry Solutions
• Aseptic Production Environment: Cleanroom (Class 1000), medical-grade solder (halogen-free), compliant with IPC-A-610 Class 3 standards
• End-to-End Traceability System: Establishing a complete traceability system from supplier qualification verification and batch number recording to production process parameters, testing data, and operator records.
• Rigorous Quality Testing: Performing FDA-approved reliability testing, including multiple stages such as accuracy testing, sterility testing, and aging testing, ensuring zero-defect product delivery throughout the entire process.

Medical and Medical Aesthetics & Wellness

Section 3, Real-world Project Cases
Portable In Vitro Diagnostic Equipment: We provide PCBA assembly services for diagnostic instruments. The delivered PCBAs have passed FDA testing with a 100% pass rate, helping clients quickly pass regulatory approvals. They have been applied in batches to 20+ top-tier hospitals with zero complaints and zero incidents.

Section 4, Authoritative Certifications
• ISO 13485 Medical Device Quality Management System Certification, IPC-A-610 Level 3; all processed materials have passed FDA biocompatibility testing.
• US FDA Medical Regulations Compliance Certification
• EU CE Medical Device Certification
• 20+ years of experience in medical PCBA processing, equipped with a Class 10,000 cleanroom and medical-grade testing equipment.

Medical and Medical Aesthetics & Wellness

5 technical indicators	1. Mounting accuracy: ±0.01mm, meeting the precision assembly requirements of micro medical devices.
	2. Biocompatibility: Nickel-containing processes are prohibited in surface treatment; gold plating layer thickness >1.27μm.
	3. Aseptic standard: Manufactured in a Class 8, 10,000 cleanroom, with aseptic control throughout the process.
	4. Aging test: Failed to withstand 2000 hours of salt spray + 85℃ high-temperature aging test.
	5. Signal accuracy: ADC effective bit depth ≥20 bits.

3 industry pain points	1. Medical equipment is directly related to life safety, requiring guaranteed signal acquisition accuracy and low noise.
	2. It must comply with multiple medical regulations such as ISO13485, FDA, and CE, and has high requirements for material biocompatibility.
	3. The equipment must maintain an extremely low failure rate throughout its lifespan (5-10 years) to avoid downtime risks.