Medical Device & IVD Regulatory Consulting Services
Services
We specialize in providing comprehensive solutions tailored to meet the unique needs of the medical and IVD device industry
MedoQi offers comprehensive medical device services, supporting regulatory compliance across major global markets including the EU, USFDA, TGA (Australia), Health Canada, CDSCO (India), and 75 other countries. Our services cover the entire product lifecycle, from initial design through post-market stages, ensuring adherence to international standards and efficient market entry. With specialized expertise in quality, regulatory, and clinical domains, MedoQi is your trusted partner for navigating the complexities of global medical device regulations.
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.
Regulatory Services
MedoQI offers a comprehensive range of regulatory services designed to support medical device manufacturers in navigating the complex landscape of global regulatory requirements.
Quality Management System (QMS) Services
A Quality Management System (QMS) encompasses a set of structured processes, policies, and procedures designed to ensure that medical devices are safe, effective, and compliant with international regulatory standards.
Medical and Clinical Writing Services
MedoQI offers a comprehensive range of clinical evaluation services designed to ensure that medical devices meet regulatory requirements and achieve market success. Our services span from strategic consulting and clinical writing to claims management and clinical file maintenance, providing end-to-end support for clinical evaluation processes.
Engineering Services
MedoQI Engineering Services offer a comprehensive suite of solutions designed to ensure the quality, safety, and compliance of medical devices throughout their lifecycle. Our expertise spans across various critical areas, including quality engineering, software as a medical device (SaMD), design quality engineering, and product risk management.
PMS and Complaints Handling
At MedoQI, we offer comprehensive Post Market Surveillance (PMS) and Complaints Handling services to ensure the continued safety, efficacy, and compliance of medical devices. Our services are designed to support manufacturers through the entire lifecycle of their products, from market introduction to post-market monitoring.