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Domestic and Overseas Medical Device LegalCompliance Consultation / Support
International medical device regulatory investigationInternational medical device regulatory translation servicesSales 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, CosmeticsEurope : MDD MDROther 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 reportUSA : IDE PMA 510K application, etc.Europe : Class compatibility evaluation procedure, creation of technical fileOther 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 OrdinanceUSA : QSR
Europe : MDD、MDRCommon to all countries: ISO13485
■ QMS System Creation
www.accuthera.com2-8-22 Kurigi, Asaoku, Kawasaki-City, Kanagawa, JapanTel. 044-980-1511 Fax. 044-980-1522E-mail : [email protected]
Accuthera Inc.
