Regulatory Compliance
Here you’ll find the quality management system certification information as well as product approvals for medical products.
QUALITY MANAGEMENT
Europe
g.tec medical engineering GmbH is certified according to EN ISO 13485.
Japan/Canada/USA
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 (pdf)
- Product certificate database (web)
- Declaration of Conformity for g.Estim PRO
- Declaration of Conformity for cortiQ
- Declaration of Conformity for recoveriX
- Declaration of Conformity for g.Nautilus PRO
- Declaration of Conformity for g.Nautilus Research
- Declaration of Conformity for g.HIamp
- Declaration of Conformity for g.Estim FES
USA
g.tec medical engineering GmbH is a FDA registered company:
FDA cleared products according to 510(k):