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)
FDA cleared products according to 510(k):
- cortiQ | K191432 (upon request)
- g.HIamp | K123255 (upon request)
- g.Nautilus PRO | K171669 (upon request)
- g.Estim PRO | K173684 (upon request)
- g.Estim FES | K200088 (upon request)