Our Medical Device RA/QA Services

Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers.

Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.

EU MDR Gap Analysis

A comprehensive first step towards MDR compliance.

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UDI Consulting

Manage, maintain, and distribute your product data with precision and efficiency.

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Global Consulting

Addressing a changing regulatory environment.

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CER / CEP Writing

CER/CEP writing services to streamline your Clinical Evaluation process.

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Post Market Surveillance

Design and implement surveillance processes to increase compliance and reduce risks.

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