Clinical Evaluation Center for Devices|Medmonts

Clinical Evaluation Center for Devices

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Clinical Investigation

Clinical Evaluation

Medical Standards

Our Parent Concern

CLINICAL INVESTIGATION

Clinical Investigation is a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. Clinical Evaluation Center for Devices (CECD) undertakes an extensive clinical investigation and documents the entire process efficiently.

FREQUENTLY ASKED QUESTIONS

CLINICAL EVALUATION

Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter. The Clinical Evaluation Center for Devices (CECD) takes care of the complete clinical evaluation process with ease!

CLINICAL EVALUATION REPORT

CLINICAL EVALUATORS

FREQUENTLY ASKED QUESTIONS

MEDICAL STANDARDS

The core success of Medmonts CECD lies in adhering to the compliance of both EU MDR 2017/745 and MEDDEV 2.7.1 Rev 4, thereby ensuring the safety and performance of the medical device that is evaluated.

EU MDR 2017/745

MEDDEV 2.7.1 REV 4

CONTACT

US

Scienstar 1013, 42, Magok-JoongAng-6ro, Gangseo-gu, Seoul, 07802, South Korea

wpark19@gmail.com

VISIT

US

Monday - Friday 11:00 - 18:30

Saturday 11:00 - 17:00

Sunday 12:30 - 16:30

MEDMONTS Consulting