ABOUT US
New Criteria Consulting focuses on the Medical Device and In-vitro Diagnostic Device Sector and aims to aid manufacturers and distributors to enter or maintain their presence in the “European Market” by ensuring their adaptation to the new European Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
After the adaptation of MDR and IVDR, the manufacturers are now required to act under the guidelines of these two regulations in order to market their products in Europe. With our team of experienced specialists, we guide our customers through their adaptations to the new regulations of the European Union on medical and in vitro diagnostic devices.
Our vision is to understand the needs of our customers and help them achieve their aims in the EU/USA by our dedicated partners and personnel, who would give utmost importance to quality and customer satisfaction.
Our team includes highly-experienced experts in IVDR, MDR, and other regulations with expertise in not only quality management of medical devices and in vitro diagnostic medical devices but also their research & development, and manufacturing.
Our team members include dynamic experts with PhD degrees from world-renowned institutions in the areas of molecular biology, engineering, microbiology, virology, and biotechnology as well as physicians specializing in biochemistry and pharmacology, and pharmacists, all of whom have extensive experience.
Our vision is to understand the needs of our customers and help them achieve their aims in the EU/USA by our dedicated partners and personnel, who would give utmost importance to quality and customer satisfaction.
Our team includes highly-experienced experts in IVDR, MDR, and other regulations with expertise in not only quality management of medical devices and in vitro diagnostic medical devices but also their research & development, and manufacturing.
Our team members include dynamic experts with PhD degrees from world-renowned institutions in the areas of molecular biology, engineering, microbiology, virology, and biotechnology as well as physicians specializing in biochemistry and pharmacology, and pharmacists, all of whom have extensive experience.
Let's get in touch!
Feel free to write us via e-mail or leave your info below and we'll contact you as soon as possible
CHINA: Shanghai Llins Technology Co., Ltd., Room 812, Building 90, No. 1122, Qinzhou North Road, Xuhui District, Shanghai 200233, P.R. CHINA
USA: 1325 w. Wilson 60640, Uptown Chicago, IL, USA
GERMANY: Mittelstrasse 12/14 33602 Bielefeld, GERMANY
JAPAN: 2-14-6-301 Morishita Koto-ku, Tokyo, JAPAN
TURKIYE: Koç İkiz Kuleleri, Söğütözü Mahallesi
Söğütözü Caddesi, D Blok, No: 2/34, Çankaya, Ankara, TURKIYE