November 28, 2025

Arkona with MDR Certification!

Arkona
CONTENTS

We Have Our MDR Certificate!

This is a truly special moment for us. On November 4th, 2025, ARKONA officially obtained MDR certification — and the road to this milestone was anything but easy. It’s one of the toughest challenges medical device manufacturers face today: demanding regulations, a long, multi-step process, and extremely high standards. Hundreds of pages of documentation, months of analyses and audits.

That’s why we’re even more proud to be among the first companies in Poland producing medical devices to have completed this process from start to finish.

For us, it’s not just a certificate. It’s proof that our daily work and commitment to quality truly matter. MDR certification confirms that we can confidently operate on the European market, delivering products that meet the expectations of both doctors and patients.

Today, we celebrate. This is an important step in ARKONA’s history and a major reason for our entire team to be proud. We want to thank everyone who has trusted us and helped us grow over the years.

We’re moving forward — with even greater responsibility and motivation.

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Information

In accordance with the applicable law, this website and its content presented on it are intended solely for professionals in the field of medical devices, i.e., in particular persons practising a medical profession or trading in medical devices and their employees or associates, as they contain advertising messages for products intended for use by users other than laypeople.