Qnet LLC

QNET is a quality assurance and regulatory affairs consulting firm that specialized in cost effective CE marking.

QNET provides consulting services that help manufacturers comply with the Medical, IVD, Machinery, PED, and ATEX Directives. Imlplementation of Quality management systems: ISO 9000, ISO 13485 and USA-FDA QSR. FDA 510(k) preparation and submission. QNET's CE Marking services for Medical Devices include the compilation of the Technical File as required under EU Directive 92/42/EEC for all Risk Classes. QNET's Machinery, ATEX and PED 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. QNET is an Authorized Representative for Medical Devices and Machinery in the EU.