Regulatory Compliance

Here you'll find the quality management system certification information as well as product approvals for medical products.

Quality Management System

Europe

g.tec medical engineering GmbH is certified according to EN ISO 13485.

Quality Management System Certificate (pdf)

Product Certificate Database

Japan | Canada | USA

MDSAP - Medical Device Single Audit Program (pdf)

Certification / 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

Declaration of Conformity

  • g.Estim PRO | DOC

USA

g.tec medical engineering GmbH is a FDA registered company: Company Registration Information USA

FDA cleared products according to 510(k):