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Industries

Medical Devices

Life-critical cable assemblies, PCBAs, and electromechanical systems built to FDA, ISO 13485, and IEC 60601 standards.

Where Quality Is a Matter of Life

Medical device manufacturing requires an uncompromising commitment to quality, traceability, and regulatory compliance. AMTG's medical manufacturing programs are built on robust quality management systems, full lot traceability, and rigorous process controls that satisfy FDA 21 CFR Part 820 and ISO 13485 requirements.

From implantable device interconnects to diagnostic imaging cable assemblies, our team brings deep expertise in biocompatible materials, sterilization-compatible designs, and the documentation rigor that medical OEMs require. Every assembly ships with a complete device history record (DHR).

Standards & Certifications

ISO 13485:2016
FDA 21 CFR Part 820
IEC 60601 Compliant
ISO 9001:2015
Full DHR / Lot Traceability
Biocompatible Materials

Applications

Diagnostic Imaging

High-voltage and signal cable assemblies for MRI, CT, ultrasound, and X-ray systems.

Patient Monitoring

Biocompatible cable assemblies and PCBAs for bedside monitors, ECG, and vital signs equipment.

Surgical Robotics

High-flex, sterilization-compatible cable assemblies for robotic surgical systems.

Implantable Devices

Ultra-miniature, biocompatible interconnects for pacemakers, neurostimulators, and implants.

Infusion & Drug Delivery

Precision cable assemblies and PCBAs for infusion pumps and drug delivery systems.

Laboratory & Diagnostics

Assemblies for in-vitro diagnostic (IVD) instruments and laboratory automation equipment.

Trusted by Leading Medical Device OEMs

Let's discuss your medical device assembly requirements and compliance needs.