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.

Post Market Surveillance

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

Post-Market Clinical Follow-up (PMCF) Guidance

Meet your PMCF requirements to comply with EU MDR.

EU MDR Gap Analysis

A comprehensive first step towards MDR compliance.

CER / CEP Writing

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

IVDR Consulting

We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation.

Medical Device Consulting

Addressing a changing regulatory environment.

UDI Consulting

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

EU Authorized Representative Services

Manufacturers selling Medical Devices in Europe but located outside of Europe (3rd countries) need to appoint a Europe based Authorized Representative (AR) in order to place a medical device on the EU market as required by the new MDR 2017/745.

Additional Information

Download the latest brochure of our capabilities and services.

Pharmaceutical Industry Regulatory Affairs - Celegence