1 year before end of transition period: Ondal holds MDR certificate

On November 11, 2022, the one-week MDR audit concluded our MDR certification activities (Annex IX)...

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On November 11, 2022, the one-week MDR audit ended at Ondal. During this week, three auditors from the notified body audited virtually all processes at Ondal Medical Systems GmbH and checked whether they met the requirements of the MDR.

This was preceded by the multi-day audit of the technical documentation of the latest risk class IIb product and the three-day audit of the documents of our quality management system.

We are pleased to announce that all our certification activities have been successfully completed.

Now the time of waiting for the MDR certificate begins, possibly there will be some queries during the reviews. We expect that it will take several months before the certificate is issued.

We are proud of the fact that we will probably have our certificate in our hands more than 1 year before the end of the transition period (26.05.2024) and therefore will not be in the hectic of the last year of the transition period like many other companies.

In addition, our MDD certificate is also valid until 26.05.2024 .