Internationally experienced QRM team
Right from the outset, quality has been at the core of BONESUPPORT™. In order to set up a state-of-the art quality system and secure quality procedures in all research and business activities. BONESUPPORT™ has recruited an experienced QRM team with extensive experience from the international medical device arena.
Standards
The quality system within BONESUPPORT™ complies with the international standard ISO 13485:2003 “Medical devices - Quality management systems - Requirement for regulatory purposes“ and the FDA standard 21 CRF part 820 “Quality System Regulations“.
ISO 13485:2003 certification
As a result of the structured quality work within BONESUPPORT™, the company is certified according to ISO 13485:2003.
EU View/Download certificate (PDF, 519 kb)
Canada View/Download certificate (PDF, 365 kb)
