Regulatory Compliance | g.tec medical engineering GmbH
Regulatory Compliance
Here you’ll find the quality management system certification information as well as product approvals for medical products.
QMS Certificate (upon request)
Product certificate database (upon request)
QUALITY MANAGEMENT
Europe
g.tec medical engineering GmbH is certified according to EN ISO 13485.
Japan/Canada/USA
MDSAP – Medical Device Single Audit Program (upon request)
CERTIFICATION AND APPROVALS
Europe
CE-Certification according to directive 93/42/EEC, Annex II:
EC Certificate for active and passive stimulation devices for neurological diagnosis and therapy devices for neuromuscular stimulation devices (upon request)
Product certificate database (upon request)
Declaration of Conformity for g.Estim PRO (upon request)
Declaration of Conformity for cortiQ (upon request)
Declaration of Conformity for recoveriX (upon request)
Declaration of Conformity for g.Nautilus PRO (upon request)
Declaration of Conformity for g.Nautilus RESEARCH (upon request)
Declaration of Conformity for g.HIamp (upon request)
Declaration of Conformity for g.Estim FES (upon request)
Declaration of Conformity for g.SENSOR 8 fNIRS (upon request)
USA
g.tec medical engineering GmbH is a FDA registered company:
Company Registration Information USA (upon request)