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 the clinical safety and performance of the medical device in accordance with the requirements of the European Medical Devices Directive. 

Clinical Evaluation offers the following benefits to your business:

  • Avoid major pitfalls of clinical regulatory submissions

  • Provide detailed documentation on performance and clinical safety of your medical device

  • Ensure continuous compliance throughout the lifecycle of your medical device

How Can We Help?

We are here to assist you through the complicated process of Clinical Evaluation and help you in getting approval without any hassles. 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:

  • Determine whether a clinical investigation is required for your medical device

  • Perform clinical evaluation in accordance with MEDDEV 2.7.1 Rev 4

  • Prepare the Clinical Development Plan for your medical device

  • Prepare the definition of scope

  • Establish design as well as intended use equivalence with the pre-existing designs and the competitor 

  • Identify data sources such as clinical trials, literature search,... 

  • Collect clinical data from literature reviews and clinical trials 

  • Prepare documents related to clinical investigations that adhere to the Notified Body requirements, only if a clinical investigation was deemed necessary

  • Assess the clinical data for measuring the safety and efficacy of the medical device

  • Assess the clinical data for identifying risks and contraindications of the medical device

  • Implement risk evaluation, both pre-review, and post-review

  • Identify residual clinical risks and determine whether there is a necessity for post-market clinical follow-up 

  • Maintain and also update the documentation pertaining to clinical evaluation throughout the post-market medical device lifecycle

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