Certification through a neutral and independent body provides proof of compliance with industrial, legal, and normative requirements, thus creating trust in the provision of products and services.
The Powertube is certified in Europe with the following standards:
What is MEDCERT?
MEDCERT is one of the biggest certification and Notified Bodies in Germany, and are notified for Directives 93/42/EEC and 90/385/EEC concerning medical devices. MEDCERT is exclusively active in the field of medical devices.
Certification services include:
- Certification according to ISO 13485
- Certification according to the Council of European Communities Directive 93/42/EEC concerning medical devices
- Certification of medical devices of animal origin according to Commission Regulation (EU) No. 722/2012
- Certification of active implantable medical devices according to Directive 90/385/EEC
Therapeutic Goods Administration
The Powertube is registered as a medical device (included Class IIa) in Australia with the Australian Register of Therapeutic Goods (ARTG), under the Therapeutic Goods Administration (TGA):
- ARTG 140656 - Stimulator, electrical, analgesic, peripheral nerve transcutaneous
What is the Therapeutic Goods Administration?
The Therapeutic Goods Administration is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989 (Cth). The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
What is the Australian Register of Therapeutic Goods
Therapeutic goods entered in the Australian Register of Therapeutic Goods (ARTG) can be lawfully supplied in Australia.
The Powertube was certified previously with the TÜV in Germany; however, it was decided not to renew this as certification with the more appropriate MEDCERT has been accomplished.