Quality Guideline

Our ambition

The quality of our medical devices is guaranteed by continuous improvement of both internal and external processes, as well as rigorous design verification during product development. 

Our objective

Our objective is to provide safe and effective devices that improve the quality of spine care and meet customer and regulatory requirements.. 

Our commitment

Quality management involves everyone in the company, and it is our goal to continuously optimize the quality of our medical devices. Our quality management system was certified in accordance with DIN EN ISO 13485 in 2005 when Paradigm Spine was founded, and compliance is regularly monitored by TÜV Sud Product Service GmbH. 

Our certificates

EC Certificate Implants - G1 certificate.pdf

EC Certificate measuring instruments - G2M EC certificate.pdf

ISO Certificate - ISO 1385 certificate.pdf