Regulatory Compliance | g.tec medical engineering

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)