Young and innovative company, creating tools for medical device companies, and for requirements management.
Mission: Help medical device companies to manage their documentation in a structured way, in order to speed up the process of certification.
Our applications generate the traceability, emphasize the missing elements in the design, provide a risk analysis.
The Design History File needed for ISO13485 and FDA certification is made much easier with our application.
Main product: Matrix Requirements Medical, a tool to help small medical devices companies organize their documentation to ease all agency approvals.
The emphasis is made on the traceability and the audit.
The system can be used to generate documentation for CE mark, ISO13486, FDA, etc…