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Medical devices

Medical devices are a broad category of products used in medical care for the diagnosis, treatment, monitoring or rehabilitation of patients. They range from simple aids such as bandages and thermometers to complex devices such as pacemakers, diagnostic equipment or implants. In contrast to medicines, which contain pharmacological active ingredients, medical devices mainly work through physical, mechanical or electronic functions.

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Medical device registration test

The biocompatibility assessment of medical devices in accordance with EN ISO 10993-1 serves as a prerequisite for approval and for testing your products for biological safety in order to minimise risk. As a manufacturer or authorised representative, you are responsible for the risk assessment of your product.

Depending on the intensity and location of the medical device and the contact with the specific organs as well as the duration of contact with the medical device, it is defined which tests are necessary for regulatory purposes.

Please contact us if you require additional or different tests or would like a customized study design!

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We advise you in the following areas:

Physical and chemical tests

Skin-/ eye irritation & corrosion

Acute / subchronic / chronic toxicity

Genetic and reproductive toxicity

QSAR

Do you need additional tests or an individualized study design?

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+ 49 30 843 13 661
info@toxlicon.com

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Find out more about our services

We offer a comprehensive range of services that includes scientific and regulatory consulting, the development of test strategies for regulatory approvals, test and project support and the commissioning of laboratories.
We also provide support with professional study monitoring for GLP studies and the preparation of complete authorisation dossiers. Our services can be flexibly tailored to your needs, either individually or as a customised package.