Qualys Innova
Qualys Innova introduces a design and a manufacture concept of U.S. FDA QSR (cGMP), brings the value of an advanced quality design, product quality, and a risk hedge to medical equipment, and helps development of the product with which it is full of ingenuity. Moreover, the solution of key factors for medical devices business success in Japan, product quality, risk management, and OEM/TPM products is offered, corporate innovation is accelerated, and the soil which produces innovative ideas is created.
We are the only contractor in Japan
of U.S. Major Medical Device Company !!
OutsourcingFair internal and supplier audits as an independent bystander / Any improvement projects based on Six Sigma method | FDA Inspectionthe preparation of FDA Inspection | FDA GMP ( QSR )System constructions of FDA GMP ( QSR ) | ||||||||
Medical Device DevelopmentOEM development of Medical Device in Japanese market. / Application to MHLW and testing for application | FDA SeminarGMP ( QSR ), QSIT, CAPA, P&PC, Design Control, Software validation, Trend of FDA the latest administration / In-house Training | | ||||||||
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