In Vitro Diagnoistic

tirc is a mature medical contract manufacturing engineering and design partner focusing on the development of medical in vitro diagnostic device (IVD) products. Regulatory compliance requirements include:

  •     Software Development Life Cycle complies with ISO/ IEC 62304

  •     Software Test Plan complies with ISO/ IEC 29119

  •     Risk Evaluation and Management complies with ISO/ IEC 14971

  •     Quality Management complies with ISO 13485

  •     Product Electrical Safety complies with IEC61010 / IEC60601

 

Mainly for IVD related products in the past complicated biochemical process steps, providing a complete solution for Robotic Healthcare on the automation of healthcare and biomedical robots.

Including the micro-step precision control of the stepping motor on orifice plate transfer, and pipetting mechanism, cleaning, magnetization, vibration, heating, dispensing reagents, lighting and the optical design of the fluorescent microscope, combined with shooting and AI image recognition, specimen pre-preparing, liquefaction standard bottle, culture dish, incubator and other module technologies. Provide OEM and ODM for nucleic acid testing, immunoassay, molecular assay, microbiological testing and other robotic healthcare equipment.

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Automated Precision Liquid Transfer System
Precision Injection Runner Design
Stepping Motor Precision Movement Control
Rapid Temperature Control of PCR System
Image-based Liquid Level Detection
Multi-band Fluorescent Optical System