Case Study: Clinical Evaluation of Dental Diagnostic and Therapeutic Devices
Background – Client Needs:
Celegence is providing support to several manufacturers of dental consumable materials, dental equipment, and dental imaging devices and software in authoring CEP, CER, PMSR/PSUR, and SSCPs.
Deliverables included: templates, Clinical Evaluation Report, Literature Review Report, PMSR/PSUR, SSCP for new devices to be launched on the market as well as legacy devices.
Project Initiation & Key Objectives:
The scope of Celegence activities was to create end-to-end documentation. This included creation of the Clinical Evaluation Plans including detailed search strategies for searching device-specific literature on scientific databases and adverse events on safety databases, and a robust state-of-the-art review to complement the gathered evidence.
The team was expected to summarize all manufacturer-held data, including claims, non-clinical tests, clinical investigations, and Post-Market Surveillance data. All of the gathered evidence was to be analysed and the findings from the clinical evaluation were to be used to demonstrate conformity to the relevant General Safety and Performance Requirements.
Celegence Solution & Approach:
Celegence supported the manufacturers for the following activities for their Class I, IIa, and IIb devices:
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:
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).