Clinical Evaluation Report
What is CEP?
A Clinical Evaluation Plan (CEP) is used as a road map for performing a clinical evaluation. This is the initial document that has to be prepared in the clinical evaluation process.
Why is CEP important?
In order to sell or distribute your medical device in Europe, you have to obtain CE Marking for your medical device. To acquire CE Marking, your medical device has to be evaluated and a CER has to be prepared based on the evaluation.
The submission of CE Technical File along with its associated CER is required to obtain CE Marking for your medical device from the Notified Body.
What is CER?
A Clinical Evaluation Report (CER) is used to document the conclusion of your medical device's clinical evaluation. CER is prepared according to MEDDEV 2.7.1 Rev 4 to prove that the intended purpose of the medical device is met without subjecting the patients to any added risk.
CER proves the performance and safety of your medical device either with the help of your device's clinical data or based on the pieces of literature and other studies associated with its equivalent device.
Why is CER important?
In order to sell or distribute your medical device in Europe, you have to obtain CE Marking for your medical device. To acquire CE Marking, your medical device has to be evaluated and a CER has to be prepared based on the evaluation.
The submission of CE Technical File along with its associated CER is required to obtain CE Marking for your medical device from the Notified Body.
How can we help?
We are here to assist you with the preparation of CER and Literature Reviews. We specialize in evaluating clinical data of medical devices, and we make sure that your CER adheres to the European requirements entirely. Our expert crew of regulatory experts will do an in-depth evaluation and prepare Clinical Evaluation Plan (CEP) as well as Clinical Evaluation Report (CER) and other relevant documents.
Here are the services we offer:
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Evaluate the clinical data of your medical device
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Collect and study appropriate scientific literature that is applicable to your medical device or its equivalent device
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Prepare the CEP and CER in compliance with European (EU) requirements
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Prepare procedures for the compilation of CER
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Carry out reviews of clinical literature for upcoming updates to the CER
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If required, we can create a protocol to search and evaluate journal items methodologically and offer a synopsis
CONTACT
US
Tel. 02-6264-9001
Life officetel 320, 40, 63Ro,
Youngdeungpo-Gu, Seoul,
07345, Korea
wpark19@gmail.com
VISIT
US
Monday - Friday 11:00 - 18:30
Saturday 11:00 - 17:00
Sunday 12:30 - 16:30