Would you like to know whether your product is state of the art?
What are the performance and safety parameters of your product according to the state of the art?
Are you looking for external know-how and independent expertise?
What similar products and medical alternatives are there to your product and what is their safety and performance profile?
Would you like to benefit from a comprehensive assessment of the state of the art during early product development?
Together we define the objectives of the assessment of the state of the art. We ensure that timelines are met and that the assessment is completed within your deadlines. The state of the art assessment can be performed as a separate document or together with other activities (clinical evaluation, clinical trial, risk management).
We identify all data relevant to the state of the art, including your product’s medical field and risks, alternative treatment options and data from similar products to establish parameters for evaluating safety and performance. We document our database searches in a complete and reproducible manner.
The collected data is analyzed with regard to defined safety and performance parameters. For this purpose, the data from similar medical devices and existing alternative treatment or diagnostic options are examined.
Based on the analyzed data, we develop parameters for evaluating your medical device. If the data is solid, these can be quantitative and serve as a benchmark for your product. Determining the parameters helps to determine the endpoints to be investigated and the risk acceptance thresholds to be set.
Depending on your processes, the state of the art assessment can serve as input for the clinical evaluation plan (CEP), the risk management plan or the rationale for the study design of your clinical trial.
The assessment of the state of the art is dynamic and constantly evolving. Therefore, continuous monitoring of the relevant data is required to provide regularly updated information to ensure that your product remains safe and efficient throughout its life cycle.
Depending on the classification of the device, a regular update of the clinical evaluation is required: annually for implants and class III devices or every 1-5 years for other medical devices. We support you in efficiently updating your clinical evaluation documentation.
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Before submitting your application to a Notified Body, let us perform a full CAP analysis of your clinical evaluation. We use an assessment template based on the MDCG 2020-13, as do the Notified Bodies.
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