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)