Helps manage and ensure compliance of tech documents. Supports ISO 9001, 13485 and FDA 21 CFR Part 11.
Cognidox is an affordable document management and eQMS platform that caters to scaling medical device and high-tech companies. The platform is FDA, GxP, and ISO 13485 compliant, making it ideal for medical device scale-ups and widely used in high-tech product development. It offers features such as document controls, version control, audit trails, configurable approval workflows, metadata indexing, and integrated e-signatures. Cognidox also provides design controls for managing design inputs and outputs, automating design documentation, and ensuring compliance. Additionally, it offers quality modules for managing quality processes, training matrices, complaints handling, non-conformance reports, CAPA forms, and post-market surveillance. The platform helps businesses gain ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 compliance. Cognidox is easy to implement, minimizes risk, and is cost-effective. It has received positive reviews from customers, who appreciate its user-friendly interface, powerful search facility, great support, and flexibility in supporting different workflows.