Facts & Figures

Facilities in Binzen and Lörrach (Baden-Württemberg), Germany
Manufacturing area ~ 1'000 m2
Certificates & Registrations ISO 13485
Medical devices - Quality Management System

MDD
Full quality system according to Directive 93/42/EEC on Medical Devices

AIMD
Full quality assurance system according to Directive 90/385/EEC on
Active Implantable Medical Devices

CMDCAS
Canadian Medical Devices Conformity

ANVISA
Brazilian Health Surveillance Agency

FDA registered

Australian (TGA) recognition

Japanese accreditation of foreign medical device manufacturer