At CERINTIME Tech, we understand the ever-increasing demands and requirements of the MDR. That's why we're here to offer you a comprehensive solution. From crafting precise Clinical Evaluation Plans (CEPs) and Reports (CERs) to meticulous PMCF documentation and specific literature reviews, our expertise ensures compliance with the highest standards.

Class I, Class IIa, Class IIb, Class III and implantable Medical Devices

Our services

Clinical Evaluation Plan (CEP)

The CEP is the first step to follow: setting the protocol, strategy, and direction for the Medical Device (MD) assessment.

Specific literature reviews

We conduct exhaustive literature searches to establish the state of the art (SOTA), selecting the most relevant publications.

Clinical Evaluation Report (CER)

We provide comprehensive CER writing services for obtaining CE marking under MDR.

Post-market Clinical Follow-up

We offer services to create PMCF Plans and Reports, including clinical surveys and other related documents.

Clinical Non-Conformity resolution

We can assist you in the resolution of clinical Non-Conformities received from your Notified Body (NB).

Clinical regulatory consultancy

We provide expert advice on clinical regulatory compliance in accordance with MDR.

Contact

Your compliance journey starts here!

Contact us to discover how we can support your regulatory needs and ensure your success. We look forward to hearing from you soon!

info@cerintime.com