CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Clinical Evaluation of Ophthalmological Surgery Devices and Vision Care Products
Project Summary
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.
Celegence Solution & Approach:
Celegence supported the company for the following activities for their Class I, IIa, IIb, and III devices:
Highlights:
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 Success
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..
Get in touch today
to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.
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25 Mar, 2025
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