STATE OF THE ART
YOUR TASK
The State of the Art needs to be regularly updated 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. During the State of the Art Evaluation safety and performance parameters and acceptance thresholds are established.
YOUR CHALLENGES
We focus on your demands.
Do you want to know if your device is in line with the State of the Art?
What are your devices’ performance and safety parameters based on the State of the Art?
Are you looking for external know-how and independent expertise?
Do you aim to benefit from a comprehensive State of the Art Evaluation during early product development?
What are similar products and medical alternatives to your device and what is there safety and performance profile?
YOUR BENEFITS
The State of the Art Evaluation is essential for established products as well as for products under development. It identifies risks and benefits of similar devices and medical alternatives. A strong State of the Art Evaluation is the foundation of a successful CE marking.
STATE OF THE ART AT A GLANCE
Depending on your needs, the State of the Art Evaluation can be part of our Clinical Evaluation activities or performed separately.
1
Project Kick-off
Together we define the objectives of the State of the Art Evaluation. We ensure that timelines are met and the evaluation is completed within your deadlines. The State of the Art Evaluation is documented in a stand-alone document or in close connection with the other activities (Clinical Evaluation, Clinical Investigation, Risk Management).
2
Data identification
We identify all data relevant for the State of the Art, including the medical field of your device and associated risks, alternative treatment options and data from similar devices to derive parameters for the evaluation of safety and performance. Our database searches are comprehensively and reproducibly documented in the literature search report.
3
Data analysis
The collected data is evaluated with regard to the determined 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 will be established. If the data are solid, these can be quantitative and serve as a benchmark for your product. The determination of parameters helps to determine endpoints to be investigated and risk acceptance thresholds to be set.
5
State of the Art Evaluation (SOTA)
Depending on your processes, the comprehensive State of the Art Evaluation serves as input to your Clinical Evaluation Plan (CEP), Risk Management Plan, or as study design rationale for your clinical trial.
6
Further development of the State of the Art
The State of the Art Evaluation is dynamic and constantly evolving. Therefore, continuous monitoring of the relevant data is necessary to provide regular up-to-date input to ensure your product remains safe and efficient throughout its complete lifecycle.
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Do you have any further request?
Regular CER Updates
Depending on the classification of your device, a regular update of the Clinical Evaluation is necessary: annually for implants and class III devices, or every 1-5 years for other medical devices. We can help you to perform an efficient update of your Clinical Evaluation documentation.
Inquiry
GAP Analysis
Before submitting your application to a Notified Body let us perform a complete GAP analysis of your Clinical Evaluation. We will used an evaluation template based on MDCG 2020-13, similar to Notified Bodies.
Inquiry
CRO procurement
Does your Clinical Evaluation Report conclude that it is necessary to obtain clinical data, to perform clinical investigations or PMCF studies?
Inquiry