Overview

In the ever-evolving landscape of medical device regulations, Elexes undertook a transformative journey with a renowned cochlear implant manufacturer, to craft a meticulous Clinical Evaluation Report (CER) adhering to the stringent requirements of the EU MDR.

Problem Statement

Prior to engaging with Elexes, the Client faced significant challenges in navigating the complexities of the EU MDR requirements for the creation of a Clinical Evaluation Report (CER) for their cochlear implants.

How we Helped?

Literature Search Excellence

Recognizing the significance of a thorough literature search, Elexes navigated various databases such as PubMed, Embase, and Cochrane Library. This approach ensured a comprehensive review of existing data, contributing to a more informed CER.

Integration Of Regulatory Components

Elexes seamlessly integrated Post-Market Surveillance (PMS), Post-Market Clinical Follow- Up (PMCF), Safety and Performance Report (SSCP), and Periodic Safety Update Reports (PSURs) into the fabric of the CER. This holistic approach not only met regulatory mandates but also fortified the clinical evidence supporting the cochlear implant’s safety and efficacy.

Outcome

In this success story, the confluence of regulatory expertise and proactive quality management resulted in swift MDSAP certification, opening doors to both Health Canada and the FDA. The case exemplifies the paramount importance of strategic partnerships in the dynamic landscape of global medical device compliance.

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