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.