tirc is a proven medical contract manufacturing engineering and design partner specializes in developing Medical Devices, In Vitro Diagnostic Devices (IVD), and Laboratory Instrumentation. Our experienced team can successfully undertake the complex medical field having in-depth knowledge in precision mechanism control and ICT integration expertise. We have worked with photometric, amperiometric, fluorescence technologies, and are versed with nucleic acid extraction, immunoassay analyzers, molecular assay analyzers, microbiology and bacteria haematology examming automation system.
We understand the complexities to master this industry as well as many regulations and compliance requirements. Including,
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