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Clinical Evaluation of Medical Devices
What is Clinical Evaluation?
Clinical Evaluation is very important in the lifecycle of any medical device. As part of Clinical Evaluation, one can perform literature reviews and clinical trials to collect the clinical data of similar medical devices. The collected clinical data is then used to measure the safety and efficacy of the corresponding medical device.
In addition, the clinical evaluation is also performed to assess the potential risks, contraindications and delivery mechanisms of the medical devices.
Why is Clinical Evaluation important?
Clinical Evaluation is necessary to demonstrate clinical safety and performance of the medical device in accordance with the requirements of the European Medical Devices Directive.
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Clinical Evaluation offers the following benefits to your business:
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Avoid major pitfalls of clinical regulatory submissions
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Provide detailed documentation on performance and clinical safety of your medical device
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Ensure continuous compliance throughout the lifecycle of your medical device
What are the Main Documents?
Clinical Evaluation requirements have increased dramatically since the release of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017. The process now involves two documents; the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
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For more information on CEP and CER, please visit the Clinical Evaluation Report (CER) link.
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Who are Clinical Evaluators?
The clinical evaluation should be conducted by a suitably qualified individual or a team with required competencies. Evaluators who sign the CER are responsible for its contents and may include CER Writer, Device Specialist, and Client Specialist.
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For more information, please visit the Clinical Evaluators link.
How can we help?
We are here to assist you through the complicated process of Clinical Evaluation in compliance with EU MDR 2017/745 as indicated below and help you in getting approval without any hassles.
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We specialize in evaluating clinical data of medical devices, and we make sure that the Clinical Evaluation adheres to MEDDEV 2.7.1 Rev 4 guidance document and to the European requirements entirely. Our expert crew of regulatory experts will do an in-depth clinical evaluation. Here are the services we offer:
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Determine whether a clinical investigation is required for your medical devices
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Perform clinical evaluation in accordance with MEDDEV 2.7.1 Rev 4
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Prepare the Clinical Development Plan for your medical device
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Prepare the definition of scope
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Establish design as well as intended use equivalence with the pre-existing designs and the competitor
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Identify data sources such as clinical trials, literature search,...
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Collect clinical data from literature reviews and clinical trials
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Prepare documents related to clinical investigations that adhere to the Notified Body Requirements, only if a clinical investigation was deemed necessary
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Assess the clinical data for measuring the safety and efficacy of the medical device
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Assess the clinical data for identifying risks and contraindications of the medical device
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Implement risk evaluation, both pre-review, and post-review
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Identify residual clinical risks and determine whether there is a necessity for post-market clinical follow-up
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Maintain and also update the documentation pertaining to clinical evaluation throughout the post-market medical device lifecycle
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CONTACT
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Tel. 02-6264-9001
Scienstar 1013, 42, Magok-JoongAng-6ro, Gangseo-gu, Seoul, 07802, South Korea
wpark19@gmail.com
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VISIT
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