When developing a product for the regulated healthcare market, data are often either already generated in the company or data are already available from the best available external evidence. This can often be used to position a product very precisely in the market or to prove its safety and efficacy. In addition, the analysis of existing results from daily practice can lead to considerable gains in knowledge and from this can be deduced whether a clinical study / clinical trial is necessary or which case numbers are estimated for a meaningful study, which indication or which patients should be chosen.
In the case of medical devices, this is required by the new EU Medical Devices Regulation (EU MDR 2017/745) for manufacturers of medical devices of all risk classes. In this case, this is called clinical evaluation (for more information, see below) and applies both before and after a medical device is placed on the market.
Our experience with scientific analysis covers a wide range of areas:
Use our expertise and place your product based on evidence.
We support you with longstanding experience in all tasks that result from Annex XIV of the new EU Medical Device Regulation (EU MDR 2017/745) for clinical evaluations and post-market clinical follow-up for medical device manufacturers.
We offer you full service before placing your medical device on the market for the planning of the clinical evaluation, the subsequent implementation and documentation. Take advantage of our knowledge and experience in the following areas:
We refer to the nature, classification, intended purpose and risks of your medical device, as well as the manufacturer‘s claims. Additionally, we offer you a clinical evaluation regarding the equivalence of technical, biological and clinical properties, should similar products be on the market.
You benefit from our experience in post-market clinical follow-up (PMCF) of your medical device. We offer professional support with the following competencies:
Please feel free to contact us by e-mail or telephone!
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