Lynax certified to ISO 13485
We are delighted to announce that, since 17 July 2026, our quality management system for medical devices has been certified to EN ISO 13485:2016. The certificate was issued by the certification body 3EC International.
The certification followed a long and careful preparation, and we are very pleased to have completed it successfully. We would like to thank our whole team for the enormous work they put into this process.
The certification covers the design and development, production, sale and service of nuclear medicine devices – dispensing and administration equipment. It confirms that the development, production and service of our devices follow the requirements placed on medical device manufacturers.
More news
Lynax at the EANM 2026 Congress in Vienna
This year's Congress of the European Association of Nuclear Medicine (EANM), held in Vienna on 18–20 October, was a great success for us. We welcomed many specialists from nuclear medicine departments, radiopharmacies and distribution companies at our stand and made a large number of new contacts.
Our dispensing units are certified under the MDR
We are delighted to announce another important milestone: our dispensing units have been successfully certified under the Medical Device Regulation (EU) 2017/745 (MDR) as Class I medical devices with a measuring function. EU Quality Assurance Certificate No. 2026-MDR/QA-037/A was issued by the notified body 3EC International (NB 2265) and is valid from 17 July 2026.
