QNET LLC 'Doing it Once!' consulting services are designed to assist manufacturers with their global compliance strategy. Focus is on developing and applying compliance intelligence that meets EU, US and Canadian regulatory requirements for medical and in-vitro diagnostic devices. Click here for CE Marking and FDA 510(k)details.
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.
Hazard and Risk Assessment in Accordance with the NEW Machinery Directive.
Machinery Authorized Representative Clarified for Manufacturers
Effective December 29,2009 all non-European based machinery manufacturers are required to identify a 'person' or 'entity' established in the European Union who is authorized to keep the manufacturer's technical file or have quick access to it. The Authorized Representative must have received a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term 'Authorized Representative does not describe a sales and marketing function, it describes a CE compliance/regulatory affairs function only.
The EU Commissions is strengthening its surveillance and enforcement of the CE mark program and requires that the first point of contact is the manufacturer's European Authorized Representative.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information. It is therefore of great importance to appoint an established and knowledgeable EU Authorized Representative firm, in accordance with an EU legal agreement that includes confidentiality.
QNET B.V. Amstenrade The Netherlands with offices in Minnesota USA, is a professional EU Authorized Representative firm in accordance with the Machinery, Medical and In-Vitro Diagnostic Directives, whose knowledgeable CE compliance managers have performed Authorized Representative services since 1998.
To obtain an Authorized Representative proposal please complete the following application online. Click Here.
CE-Marking Services for Machinery
EU Battery Directive 2006/66/EC went into effect 26 September 2008
EU Competent Authority Vigilance System
Who Are All These CE People?
CE Marking Medical Devices and In Vitro Diagnostic devices
EU Authorized Representative
FDA 510(k) Services
FDA US Agent
A Honey of an FDA Clearance!
Mamma-Print - Time Magazine Best Invention of 2007. Details Here
CE Mark for Machinery
ATEX- Equipment for Use In Explosive Atmospheres
New EU Machinery Directive 2006/42/EC Translation Requirements
What manufacturers need to know and do about Battery Directive 2006/66/EC
ISO 9000 and ISO 13485