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Nutritional CRO & Prüflabor

Medical devices

As a service provider with a great degree of expertise in the field of toxicological tests, we know that suitable testing methods can only be determined individually in order to do justice to the product and the purpose of use. Thanks to our comprehensive knowledge of in vitro methods, we always find a meaningful testing method for your question. We work with risk class I to IIb.

Determination of potential genotoxic effects for risk classes I to IIb

The difference between medical devices and pharmaceuticals is that the intended main effect of the medicinal products is mainly achieved in a physical way. According to Directive 93/42/EEC, medical devices mean any instruments, devices, software, substances or other objects used alone or in combination for diagnostic and/or therapeutic purposes. This includes, for example, dressings, syringes, stents or also pacemakers. Under the law, risk classes I to III are oriented towards the “vulnerability of the human body” to the respective product. This depends on the site and period of application of the product. The distinction between medicinal products and pharmaceuticals is extremely important, since legal regulations on market access and marketability are very different.

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