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Dear user of our Test expert plus,

the products of wegamed gmbh are approved as medical devices in Germany and our quality standard is certified according to the current EN ISO 13485:2016 standard with a CE certificate from TÜV Nord.

In order to maintain our certification according to ISO 13485:2016 with CE certificate, a product must be monitored after it has been placed on the market (post-market surveillance = PMS).

The long-term collection and analysis of data from the PMS is an important and essential part of improving the safety of medical devices.

It is certainly in your interest to continue working with an approved medical device in your practice – help us now and fill out our linked questionnaire! (alternatively, you can also find this in the appendix)

Thank you very much for your participation.

Our Test expert plus questionnaire is available online and can be filled out quickly.

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contact

wegamed gmbh
Am Zehnthof 189
D-45307 Essen

+49 (0) 201 185568-10
+49 (0) 201 185568-30

Note:

The devices we produce for therapy and diagnosis are certified according to Class 2A and CE marked as a medical product. This means that all devices have been tested for the highest safety standards and medical effectiveness in accordance with current requirements.

Scientific recognition is pending. Therefore, the devices may only be used to support conventional medical measures. A clinical evaluation through studies is available.

 


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