ISO Certifications

Demonstrating compliance with globally recognized standards for quality, safety, and reliability.

ISO certifications (DIN EN ISO 13485:2016 & DIN EN ISO 9001:2015)

We are proud to confirm that we have received the DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015 certifications!

The DIN EN ISO 13485:2016 certification – approved according to MepV/SR 812.213 – confirms that PlusORTHO Prothetik GmbH maintains a comprehensive quality management system that complies with international standards in the medical field. This is a promise of quality to our customers. This is intended to further increase trust in our products and provide added value for our customers.

The DIN EN ISO 9001:2015 certification – approved according to MepV/SR 812.213 – validates that our internal company processes comply with the international standard for quality management. This assures our customers that everything behind the scenes is also carried out to a high level of quality.