Domestic and Overseas Medical Device Legal Compliance Consultation / Support International medical device regulatory investigation International medical device regulatory translation services Sales of regulatory documents Others When introducing new products to the market, we provide support for general legal compliance strategies, such determining the requirements of the market to be introduced, and the contents of the system for compliance in Japan and overseas. Medical Device Legal Compliance Support Japan : Pharmaceuticals and Medical Devices Act, USA: Food, Chemicals, Cosmetics Europe : MDD MDR Other countries (South Korea, Taiwan, ASEAN, India, Russia, Brazil, etc.) European CE marking support (MDD, MDR corresponding) Country-Specific Correspondence We provide support services for each application step when exporting to countries outside of Japan or importing foreign products. Japan : Product approval, certification report USA : IDE PMA 510K application, etc. Europe : Class compatibility evaluation procedure, creation of technical file Other countries : preparation of pre-marketing application documents by class (classification) ■ Premarket Application We provide support to create minimum necessary compliance required by the laws of each country. Japan : QMS Ordinance GVP Ordinance USA : QSR Europe : MDD、MDR Common to all countries: ISO13485 ■ QMS System Creation www.accuthera.com 2-8-22 Kurigi, Asaoku, Kawasaki-City, Kanagawa, Japan Tel. 044-980-1511 Fax. 044-980-1522 E-mail : [email protected] Accuthera Inc.