Designed for companies at the earliest stages of R&D activities in order to create a full set of requirements that guide product development, ensuring you build the right device, the first time.

Our unique program couples your team's existing engineering and R&D efforts with phase-appropriate regulatory and quality management activities. These activities are then paired with our Product Lifecycle Management (PLM) Software Tool to form a foundation for smooth transition to a compliant Quality Management System (QMS) and Design History File (DHF) when your team is ready to begin clinical testing.

Designed to support companies transitioning from Precompliant activities to Compliant activities by providing products and services to make the process as seamless and straightforward as possible.

After the Quality System has been established, you’re ready to start using it to finish documenting your Design History File and other company activities. The majority of these materials were started during the Precompliance portion of your journey, but now that your team has transitioned to full compliance by doing the above Compliance Transition Program, these activities will continue as you work towards the refinement and completion of your product for submission.