Ce-Mark.com consults manufacturers to meet their global compliance strategy
Title
CE Mark Medical Devices, CE marking Machinery, EU authorized representative
Description
QNET LLC is a quality assurance and international trade-Consulting firm that specializes in cost effective CE marking in accordance with Machinery, PED, ATEX, Medical, AIMD and IVD Directives. Implementation of ISO 9000 / ISO 13485 and US-FDA QSR Quality Management Systems.
FDA 510(k) submission service consists of: Device classification research; Quality Systems Regulations (QSR) Implementation; 510(k) Preparation and Submission; FDA US Agent services for non-US manufacturers.
The QNET Network-Europe consists of a Medical/IVD/AIMD Authorized Representative office in the Netherlands and registered design engineers office for Machinery, PED and ATEX Advisory technical files. (Mesterdene Ltd-UK).
Languages
English
