The wait is finally over: MDR certificate in hand
On November 11, 2022, the one-week MDR audit concluded our MDR certification activities (Annex IX)...
On 11 November 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 a multi-day audit of the technical documentation of the latest risk class IIb product and a 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 and that we are in possession of the MDR certificates for our risk class IIb products since 23 February 2023.
This means that we have finished well before the end of the transition period (26.05.2024) and also ahead of our internal schedule.
With the receipt of the MDR certificates, our previous MDD certificate becomes obsolete.