Clinical Evaluation of Dental Diagnostic and Therapeutic Devices

Project Achievements

Based on the quality of deliverables, the scope of work was expanded to include additional documentation. Celegence continues to deliver high-quality regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

> 98% quality & timeline delivery performance, an achievement in collaborating with Celegence’s expertise

Improved compliance based on guidance from Celegence’s regulatory experts

80% of documents approved at first draft stage

Project Success

Celegence continues to provide support in creation of regulatory documentation to various dental device manufacturers. The key to the success of this partnership is the involvement of regulatory experts and implementation of quality control measures for each deliverable. Furthermore, nuanced understanding of regulations resulted in faster turnaround time and minimal review comments (0 – 1 review cycle only)..