EC Certification for medical devices and quality assurance systems
SLG is a Notified Body - registered under 0494 - entitled to carry out conformity assessment procedures according to the Medical Device Directive MDD 93/42/EEC for active medical devices.
We are notified for the following scopes:
General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
A conformity assessment is among others one condition for CE marking and for the use of the Notified Body's registration number, if required.
We provide the following conformity assessment services according to MDD 93/42/EEC:
- acc. to annex II (keyword: full quality assurance system) excluding section 4
- acc. to annex III (keyword: EC type examination)
- acc. to annex IV (keyword: EC verification)
- acc. to annex V (keyword: production quality assurance)
- acc. to annex VI (keyword: product quality assurance)
Please note: SLG Prüf- und Zertifizierungs GmbH prepares project-related quotations based on a specific client request and necessary information provided for the intended project. Quotations for our services usually state end prices which include hourly rates for services provided by SLG's employees. The hourly rates are either stated in the quotation or communicated on request. For maintaining a certification, costs for monitoring measures may arise depending on the certification programme. These costs are disclosed to the client in the quotation for the certification.