STATE OF THE ART
YOUR TASK
The state of the art must be updated regularly and has an impact on important processes in the life cycle of a medical device, such as risk management, clinical evaluation and post-market surveillance. When assessing the state of the art, safety and performance parameters as well as acceptance criteria are defined.
Your challenges
We focus on your needs.
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?
OUR SERVICE
The assessment of the state of the art is essential for both established products and products under development. It identifies the risks and benefits of similar products and medical alternatives. A sound assessment of the state of the art is the basis for successful CE marking.
STATE OF THE ART AT A GLANCE
We carry out the state of the art assessment according to your requirements. This can be part of our clinical evaluation activities or carried out separately.
1
Projekt Kick-off
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).
2
Data identification
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.
3
Data analysis
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.
4
Determination of the parameters
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.
5
State of the art Assessment
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.
6
Further development of the state of the art
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.
Get in touch with our experts!
Do you have any further requests?
Regular CER Updates
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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GAP Analysis
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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