QNET LLC - CE Mark and FDA 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.
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, The Netherlands, EC Authorized Representative office for CE marked Medical Devices, IVDD and Machinery. Our Registered Design engineers in the United Kingdom (Mesterdene Ltd.) write CE Marking Technical Files under the ATEX, Pressure Equipment and Machinery Directives.
Late News Croatia will become the 28th EU Member State in 2013
Labels and Instructions for Use must be in the Croatian language. This means that your correctly CE-Marked devices, machinery and other products may be placed on the Croatian market.
RoHS2 Directive 2011/65/EU
What Manufacturers Need To Know And Do
RoHS2 Directive 2011/65/EU Exemptions Published 9 January 2014
Italian Medical Device Registration Changes
CE Marked Risk Class I devices no longer need to be registered in Italy if the manufacturer or his Authorized Representative has registered the device in another EU member State.
How did this happen?
The US Department of Commerce's International Trade Administration (ITA) received complaints from QNET (on behalf of all its Authorized Representative clients) and Advamed (1600 members).
ITA successfully communicated these complaints to the EU Commission.
In response to the EU Commission's pressure, Italy adopted a new Decree, which brought about: 1) lifting of the Risk Class I registration requirement (if already registered in another EU State) and 2) a much streamlined registration process for the higher risk class devices.
With the assistance of the ITA, QNET helped bring about a savings of US$600-800.00 per device registration for its clients.
A prime example of how a committed Authorized Representative company can serve its clients in the EU.
Machinery Authorized Representative Clarified for Manufacturers
Assigning of an European Union (EU) Authorized Representative by American and Canadian machinery manufacturers has been clarified.
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.
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,In Vitro Diagnostic Medical Devices and Machinery directives. Go Click here for Authorized representative details.
CE-Marking Services for Machinery
Design engineering solutions - On-Site customized training - CE Mark Advisory Technical File writing - EU Authorized Representative Services - details can be found here.
CE Mark for Machinery
QNET Machinery, ATEX and Pressure Equipment design engineers utilize a unique writing process to produce equipment specific Advisory Technical Files, in the order preferred by the Competent Authorities. This includes the risk analysis, 48 essential health and safety requirements and identifies all standards used in the process. Go Click here for CE advisory technical file details.
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 on MDD and IVD CE marking go here.
FDA 510(k) Services
Device classification research, Quality Systems Regulations (QSR) Implementation, 510(k) preparation and submission. Go here for details.
ISO 9000 and ISO 13485
QNET pioneered the "keep it to a minimum" ISO 9000/13485 philosophy. Customized in-house workshops and aided hundreds of companies in North America achieve registration since 1990. Go here for details.
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
EU Battery Directive 2006/66/EC went into effect 26 September 2008
What manufacturers need to know and do about Battery Directive 2006/66/EC can be read here. PDF Format
The complete Battery Directive 2006/66/EC can be found here.
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.
Mamma-Print - Time Magazine Best Invention of 2007.
Congratulations to our client Agendia BV on their denovo 510(k) clearance
for MammaPrint®. MammaPrint is the first in vitro diagnostic multivariate
index assay (IVDMIA) cleared by FDA. MammaPrint is a gene expression
profiling test that predicts the risk of metastasis in breast cancer
CE Mark services for medical devices, machinery ce certification and European Union Authorized representative. FDA 510(k), ISO 13485 quality system, FDA US Agent, denovo 510k, European eu regulatory affairs.