Case Study: Clinical Evaluation of Ophthalmological Surgery Devices and Vision Care Products

Background – Client Needs:

A leading global manufacturer of ophthalmologic devices, a pioneer in the field of innovations in eye care, is working with Celegence for clinical evaluation of their pharmaceutical products and surgical devices for complying with the requirements of EU MDR 2017/745.

Project Initiation & Key Objectives:

The objective was creation and maintenance of Clinical Evaluation report (CER), Clinical Evaluation Plan (CEP), and Literature search reports (LSR) which are an essential part of the CE technical documentation for regulatory submissions for medical devices in the EU.

This included a comprehensive systematic literature review for the medical device and the State-of-the-Art, evaluation of non-clinical and clinical data generated and held by the manufacturer, real-world evidence from adverse event databases, and a robust analysis of the safety, performance, and benefit-risk profile of the devices to demonstrate conformity to General Safety and Performance Requirements outlined in the EU MDR.

Celegence Solution & Approach:

Celegence supported the company for the following activities for their Class I, IIa, IIb, and III devices:

  • Author CEPs, CERs, and LSRs for compliance to EU/MDR 2017/745

  • Assess adequacy of clinical data based on product history, pre-clinical and clinical studies, complaints, adverse events, and literature

  • Rapid processing and risk analysis of high-volume data

Project Achievements

Celegence continues to deliver regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

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

  • Improved compliance based on guidance from Celegence’s regulatory experts

Project Outcomes

Celegence continues to provide support in clinical evaluation documentation incorporating industry best practices.

Key to the success of this partnership is the process of involving experienced resources, working in tandem with the client’s regulatory team and Celegence’s expertise in delivering multiple documents in expedited timelines.

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