MedoQi offers comprehensive IVD services, providing regulatory, analytical, clinical, and assay development support across the EU, USFDA, TGA (Australia), Health Canada, CDSCO (India), and 75 other countries. Our services cover molecular biology, clinical diagnosis, bacteriology, hematology, virology, and protein engineering. We support the entire product lifecycle, from regulatory compliance and analytical performance to clinical trials and assay development, ensuring high-quality, globally compliant IVD products.

MedoQi offers comprehensive services for drug-device combination products, ensuring seamless integration of regulatory frameworks for both drugs and devices. We provide strategic guidance on product classification, PMoA determination, and global regulatory pathways. Our expertise covers preclinical and clinical development, risk and quality management, and international registration. MedoQi also supports lifecycle management, market access strategy, and compliance with global standards, enabling successful commercialization and post-market surveillance of innovative combination products.

MedoQI specializes in the unique challenges associated with software as a medical device (SaMD). Our services include in-depth documentation for design, performance, and development, ensuring regulatory compliance for pre-market submissions. We provide critical support for software validation, verification, cybersecurity, and compliance. Our configuration and release management services guarantee that all changes in software and hardware are properly updated and managed, adhering to IEC 62304:2006/AMD 1:2015 standards for medical device software life cycle processes.