Orthospine sa/nv is since many years certified to the Quality Management Systems ISO 9001 and ISO 13485 for the distribution of Medical Devices and associated Technical Services.
Our head office in Brussels and warehouse facilities in Nivelles are regularly audited by internal teams as well as by accredited bodies for certification services and government agencies to ensure the highest quality of operation and compliance to the latest regulatory requirements.
Notification number FAMHP distribution authorization MDD: BE/CA01/1-00142-MDD (medical devices).
Caroline Deroose
QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER
DOWNLOAD CERTIFICATES
Orthospine – ISO 9001:2015 Certificate
(Quality Management System applicable to the distribution of Healthcare Products and associated technical services)
Orthospine – EN ISO 13485:2016 Certificate
(Quality Management System applicable to the distribution of Medical Devices. Installation and service of sterilizers, washer disinfectors and electrosurgical generators)
Orthospine - GDP Compliance Certificate