Clinical evaluation of your medical devices

Clinical evaluation of your medical devices

Clinical evaluation is a process to continuously collect and assess all clinical data relating to a device to verify its clinical safety and performance. Clinical evaluation is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use and can be considered as an alternative to clinical investigations.

In the EU clinical evaluation is required for every medical device placed on the market for which no clinical investigation has been conducted.

In the United States analysis of the clinical data available for the predicate device (the device previously approved by the FDA and used as a benchmark for your product) is a part of 510(k) or PMA product dossiers. This analysis can be considered as an equivalent of the Clinical Evaluation in the EU.

Some countries have no clear standards on Clinical Evaluation. However, they require collection and analysis of pre-market clinical data as a part of regulatory submission. Mostly these countries accept Clinical Evaluations that conform to the European requirements.

Clinical evaluation is a process to continuously collect and assess all clinical data relating to a device to verify its clinical safety and performance. Clinical evaluation is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use and can be considered as an alternative to clinical investigations.

In the EU clinical evaluation is required for every medical device placed on the market for which no clinical investigation has been conducted.

In the United States analysis of the clinical data available for the predicate device (the device previously approved by the FDA and used as a benchmark for your product) is a part of 510(k) or PMA product dossiers. This analysis can be considered as an equivalent of the Clinical Evaluation in the EU.

Some countries have no clear standards on Clinical Evaluation. However, they require collection and analysis of pre-market clinical data as a part of regulatory submission. Mostly these countries accept Clinical Evaluations that conform to the European requirements.

MDRC assists medical device companies with Clinical Evaluations. We will create your clinical documentation complying with regulations of your strategic markets.

MDRC assists medical device companies with Clinical Evaluations. We will create your clinical documentation complying with regulations of your strategic markets.

Clinical Evaluation is based on existing scientific and clinical data. The European Medical Device Vigilance System guidance MEDDEV 2.7.1. rev. 4 can be used as a standard for Clinical Evaluations.

Clinical Evaluation is based on existing scientific and clinical data. The European Medical Device Vigilance System guidance MEDDEV 2.7.1. rev. 4 can be used as a standard for Clinical Evaluations.

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

Send us an email at: info@mdrc-consulting.com

Or use the contact form      

Clinical evaluation is not a one-off event but a process that is a part of your Post Market Surveillance System. Manufacturer's post-market clinical follow-up procedures should be in place and the product's Clinical Evaluation should be regularly updated.

Clinical evaluation is not a one-off event but a process that is a part of your Post Market Surveillance System. Manufacturer's post-market clinical follow-up procedures should be in place and the product's Clinical Evaluation should be regularly updated.

12+

YEARS’ EXPERIENCE

200+

COMPLETED PROJECTS

100+

REGULATORY SUBMISSIONS

50+

NEW PRODUCTS

Clinical Evaluation should be conducted by people who have experience working with scientific and clinical data. It is important not only how the evaluation is performed but also who performs it. The person who carries out your Clinical Evaluation should be qualified to do that and able to demonstrate his/her qualification. Biographical information of the evaluator has to be attached to evaluation reports, placed in the Technical File and if required submitted to the regulatory authorities.

Clinical Evaluation should be conducted by people who have experience working with scientific and clinical data. It is important not only how the evaluation is performed but also who performs it. The person who carries out your Clinical Evaluation should be qualified to do that and able to demonstrate his/her qualification. Biographical information of the evaluator has to be attached to evaluation reports, placed in the Technical File and if required submitted to the regulatory authorities.

Our experts are qualified and experienced to perform clinical evaluations for you

We have experience conducting clinical evaluations for tens of medical devices. We will be glad to help you perform evaluations of your products.

We have experience conducting clinical evaluations for tens of medical devices. We will be glad to help you perform evaluations of your products.

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whether you have a question about our solutions or need help with your new project

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