eQMSInnovation

With extensive experience in helping medical device manufacturers comply with regulatory requirements, eQMSInnovation specializes in guiding companies through the intricacies of IEC 62304 for medical device software development. Leveraging expertise in integrating JIRA and Confluence for efficient technical file documentation, eQMSInnovation helps organizations streamline the development process by capturing user needs, functional specifications, hazard risks, and testing reports, all while ensuring compliance with 21 CFR Part 11 for electronic signatures.

eQMSInnovation has successfully supported manufacturers in achieving product registration and certification across both the EU (MDR) and US (FDA) markets. Our consultancy services include crafting regulatory strategies, providing guidance at every stage of product development, and reviewing technical files for seamless product registration. Also offer specialized regulatory advice for Software and AI as Medical Devices (SaMD) and AI as a Medical Device (AIaMD) , ensuring compliance with international standards and regulatory frameworks for a successful market launch.