Technical file preliminary review and consultancy services according to ISO 13485, MDR and IVDR

Preliminary review of your ISO13485 documents before audit;

We facilitate and shorten your certification process by performing a preliminary review of your Technical Files according to MDR and IVDR before sending them to the certification body.

We support medical device and in vitro diagnostic device manufacturers in your CE certification process with our expert inspectors.

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

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