Medical-device quality
ISO 13485:2016
Quality Management for Medical Devices
Reference MD 712456
Corporate / Certifications
Certifications for regulated orthopedic supply
Quality system and market-readiness documents support distributor onboarding, tenders and regulatory review.
Credential Overview
Four pillars of market readiness
Each credential supports a distinct part of quality-system control, conformity assessment or regulated market access.
European conformity
CE Certification
European Conformity, Notified Body
Reference CE 0123
US regulatory clearance
US FDA 510(k)
Cleared for US distribution
Reference K203114
Quality management
ISO 9001:2015
Quality Management System
Reference QM 884201