STATE OF THE ART
YOUR TASK
The requirements regarding performance and clinical benefit requirements of a medical device may change at any time. We are able to support in the State-of-the-Art analysis to ensure that your product meets the high expectations of the clinical community.
YOUR GOAL
We focus on your needs.
Do you need a detailed evaluation of the generally accepted state of the art?
Do you need a database to define the state of the art requirements for your product?
Do you want to define risk acceptance limits based on the state of the art?
Are you looking for regulatory and clinical affairs support?
Are you planning a clinical trial with your medical device and need to conduct a systematic review of the existing data?
Are you looking for external know-how and independent expertise?
YOUR BENEFITS
We understand that there is no direct formal requirement for a state of the art evaluation, but we have successfully implemented such evaluations and see the benefit to medical device manufacturers - whether it is to get an overview for clinical trial planning; to meet MDR clinical evaluation requirements or as an input to risk management.
STATE OF THE ART AT A GLANCE
Depending on your needs, the State of the Art assessment can be part of our Clinical Evaluation activities or performed separately.
1
Projekt Kick-off
First, we work with you to define the objectives of the State of the Art Evaluation and agree on a timeframe so that the evaluation is completed in time for any deadlines. The State of the Art Evaluation is performed in close connection with the target activities (clinical evaluation, clinical trial, risk management).
2
Data identification
We identify clinical and generated non-clinical data on similar products and medical alternatives and fully document our database searches. Safety databases are also included in the search upon request, should they not already be covered by your PMS system.
3
Data analysis
The collected data is evaluated with regard to selected safety and performance parameters. For this purpose, data from similar medical devices and existing alternative treatment or diagnostic options are scrutinized.
4
Determination of the parameters
Based on the analyzed data, parameters for the evaluation of your medical device should be worked out. If the data are solid, these can be quantitative and serve as a benchmark for your product. For clinical trials, the parameters help to determine which endpoints should be investigated. For risk management, risk acceptance limits can be set based on the data.
5
State of the Art Evaluation (SotA)
The State of the Art Evaluation may serve as input to your clinical evaluation plan (CEP), risk management plan, or study design rationale for your clinical trial, depending on your processes.
6
Further development of the state of the art
The state of the art is dynamic and constantly evolving. Therefore, continuous monitoring of the relevant data is necessary to provide regular up-to-date input for your processes.
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Do you have any further requests?
Regular CER Updates
Depending on your risk category, we can help you perform the required updates for your Clinical Evaluation – whether it be annually, for implants and or Class III devices, or every 1-5 years for your other medical devices.
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GAP Analysis
We thoroughly review your Clinical Evaluation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones.
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CRO procurement
You require a clinical trial, but who is the right partner to conduct it? We can help you select a suitable CRO and provide advice and support during the clinical trial.
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