Printed circuit board for medical applications

Medical-grade PCBA designed and produced by TECOO to meet ISO 13485 requirements, delivering traceability, safety and reliable performance for clinical and diagnostic devices.

Overview
Engineered for mission-critical healthcare applications, the assembly is manufactured in fully controlled environments with rigorous process validation and documented quality procedures to ensure consistent operation in clinical and diagnostic settings.

Key manufacturing and quality controls

• Complete component sourcing and end-to-end traceability.
• Enhanced soldering standards and controlled solder processes.
• Automated Optical Inspection (AOI) and structured functional testing for defect detection.
• Risk-control protocols and documentation aligned with ISO 13485 and FDA-oriented practices.

Typical applications

• Patient monitoring systems
• Infusion pumps
• Medical imaging equipment
• Wearable medical devices
• Other precision healthcare electronics

Production capability
Supports high-mix, low-volume production as well as scalable mass-production workflows to help medical OEMs accelerate development while maintaining regulatory compliance and documented quality records.

Technical specifications

• Product type: Medical-grade Printed Circuit Board Assembly (PCBA)
• Certification: ISO 13485 certified manufacturing
• Manufacturing environment: Fully controlled production with process validation
• Quality controls: Component traceability, enhanced soldering, AOI, functional testing, risk-control protocols
• Regulatory alignment: Processes aligned with ISO 13485 and FDA-oriented requirements
• Production scale: From high-mix/low-volume to scalable mass production
• Manufacturer: TECOO