QNET Specializes in cost effective CE marking of Medical Devices and Machinery, Implementation of Quality Management Systems: ISO 9000, ISO 13485 and US-FDA QSR.
The QNET LLC Network-Europe consists of QNET BV, a Medical/IVD Authorized Representative office in The Netherlands and a Registered design engineers office for Machinery, Pressure Equipment and ATEX Advisory Technical Files in the UK (Mesterdene Ltd).

EU Competent Authority Vigilance System
In an effort to harmonize vigilance reporting in the EU, the European Commission published meddev document 2.12/1 rev 5, based on the Global Harmonization Task Force November 2006 vigilance guidance document. However Meddev documents are not legally binding and QNET device experts realized a need to determine if all EU Competent Authorities were willing to accept incident reports based on meddev 2.12/1 rev.5, and decided to contact all for a response to two simple questions during January 2008. The complete report can be Read Here - PDF Format

Who Are All These CE People?
This article in plain English explains the role of the EU Commission, Competent Authorities, Notified Bodies, Manufacturer and Authorized Representative. Read Here - PDF Format

CE Marking Medical Devices and In Vitro Diagnostic devices
QNET Medical device experts deliver consultancy to comply with the Medical Device and IVD Directives in seven easy steps. For more details go here.

EU Authorized Representative
Through it's offices in The Netherlands, QNET offers American and European clients EC Authorized Representative service in accordance with the requirements of the Medical Device and In Vitro Diagnostic Medical Devices directives. Go here for details.

FDA 510(k) Services
Device classification research, Quality Systems Regulations (QSR) Implementation, 510(k) preparation and submission. Go here for details.
Our FDA Services brochure is available here.

FDA US Agent
FDA US Agent services for non-US manufacturers. Contact QNET for details.

A Honey of an FDA Clearance!
Please join us in congratulating our client Theo B.V., in The Netherlands, on receiving one of the first ever 510(k) clearance for honey containing wound dressings - L-Mesitran Dressing Family- with the assistance of QNET's Barbara DeBiase.