Design and Development Software
Manage the whole design & development process according to strict compliance regulations and bring your medical device to market faster. Linking documents together through folders isn’t going to cut it. Have you tried this with MS Word and Excel files? Or even with standard document management solutions? We know, it doesn`t work. Let our Design & Development module do it for youOur Design & Development module is purpose-built to impeccably follow the process as stipulated by the ISO 13845 regulation, no risky shortcuts! We make it easy to link elements, maintain version control, use compliant electronic signatures and streamline risk assessment.
Connect items together seamlessly with version control as well as all necessary review and approval steps in place.
Risk assessment exercises can be performed and linked to elements painlessly in every single step of the process.
Say goodbye to having to deal with updating traceability manually. Once elements are connected through integrations, the traceability matrix is generated and kept up-to-date automatically, and effortlessly.
Our module makes it easy to export all the relevant data quickly into a universally accepted and compressed .ZIP package in order to send it off to regulatory bodies for approval.