First MDR certified treadmills at h/p/cosmos

First MDR certified treadmills at h/p/cosmos
08 Mar 2023

EU Declaration of Conformity for MDR treadmills

Yesterday, the first EU Declaration of Conformity according to the new Medical Device Regulation MDR (EU) 2017/745 for the risk class IIb medical devices got signed. Therefore, as of yesterday, the latest design treadmill series quasar and pulsar with MCU6 user terminal are now available as medical grade devices.

Under the overall guidance of Authorized Signatory and PRRC Nadine Schott, h/p/cosmos received the MDR certificate for medical devices in November 2022. Now, few months later and under the lead of R&D Project Manager Manuel Bernauer, the first EU Declaration of Conformity according to Medical Device Regulation MDR (EU) 2017/745 was signed for quasar med and pulsar med with MCU6.

Last year’s MDR quality management certification was paving the necessary “regulatory way” for this step.

Looking back on 35 years of experience in developing and manufacturing high profile diagnostics and rehabilitation treadmills, ergometers and speedlab devices, this step can be seen as a giant leap and milestone in the company history.

The new MDR certified treadmills are already listed in EUDAMED Database under Economic Operator Manufacturer SRN: DE-MF-000006147

Franz Harrer, Co-Founder and CEO as well as Dr. Björn Zimmermann, Authorized Signatory, took the chance to thank Manuel Bernauer, Nadine Schott and of course the complete involved R&D team and other team members after yesterday’s Gatekeeper Meeting for Gate 4 (market phase with EU DoC).

We would also like to thank all partners, suppliers and customers for their support in the development and path to market maturity.

A very special thanks is dedicated to our customers and partners involved in the pilot series and field test devices for this treadmill series. It was of tremendous help and massive effect to receive the feedback during the usability tests as well as during the validation process for the medical devices.