Quality & Certification

Quality you can rely on

Quality comes first at SPORLASTIC. Our quality management system includes detailed organisational rules and testing instructions so that every product consistently meets the highest standards.

ISO 13485

SPORLASTIC's quality management system is certified to ISO 13485, the international standard for medical device manufacturers.

CE marking & EU Medical Device Regulation

As a manufacturer of Class I medical devices, SPORLASTIC demonstrates conformity through the conformity assessment procedure, an EU declaration of conformity and the CE mark. Our medical devices meet the requirements of the EU Medical Device Regulation (EU) 2017/745.

OEKO-TEX® STANDARD 100

The OEKO-TEX® STANDARD 100 label confirms that SPORLASTIC textiles are tested for harmful substances and that we follow environmental regulations in manufacturing.

Mittelstand Global

SPORLASTIC takes part in the German Federal Ministry for Economic Affairs' Health Economy Export Initiative, which supports German health products and services worldwide.

Certificates and declarations of conformity can be downloaded from the SPORLASTIC certification page.