We provide objective analysis and evaluation of clinical data to help you introduce your medical devices to the market quickly.
During the Clinical Evaluation process, we collect, assess, and analyze the clinical data of your medical device in order to confirm its safety, performance, and clinical benefit.
The 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.
The Safety and Clinical Performance Report (SSCP) has been mandatory for manufacturers since the Medical Device Regulation (MDR) was introduced in 2017. We will support you in meeting the increased level of requirement.
Market surveillance (PMS)
We conduct active market surveillance for you and develop appropriate Post-Market Surveillance strategies for your medical device. As a result, we can identify complications and trends early on and ensure safer medical devices on the market.
We monitor and analyze the use of your medical device in order extend the range of clinical data available to continuously improve the evaluation of your device’s performance and also identify unknown risks.
A carefully-conducted risk analysis can already significantly improve a medical device's safety, even while it is still in the development phase. Consequently, potential risks associated with the device can be recorded and minimized by taking appropriate measures.
Biological evaluation (BEV)
As a manufacturer, you must ensure the biocompatibility of your product. Biological risks, e.g. materials that cause allergic reactions, must be minimized. We can help you to meet the requirements according to the ISO 10993 standard.
Quality Management (QM)
Prior to market launch, your medical device must undergo a conformity assessment procedure. Depending on its class, a certified QM system, according to MDD and MDR, is mandatory. We are happy to support and advise you in this regard.
The evaluation process includes clinical performance, analytical performance, and scientific validity. This ensures that your medical device meets safety requirements, achieves the intended clinical benefit, and complies with the requirements of the IVDR.
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