Qualys Innova

Qualys Innova is an expert of FDA focusing to medical device & IVD.

Over not only the prepare project for accommodating to the FDA inspections based on extensive experience, FDA-GMP (QSR) compliance, but FDA seminar preaching the medical device development principle in unique approach and changing awareness of participants, contracting of the multi support internal audit for QSR, ISO and the Pharmaceutical Affairs Law ( Japan ), contracting of supplier audit, and contracting of the OEM product development contracts that was in the market in Japan, the high quality measure of Qualys Innova own accelerates your innovation.

With experience of auditting the plant in the world as FDA support corporate audit staff of GE healthcare with 100 or more factories and performance of supporting many improvement projects as GE six sigma Black Bert, the seminar for FDA preparation which changes mind of the employee completely not only observing FDA regulatory requirement but focusing on the product quality which is the essence of the regulation, and GAP audit are very popular.

Qualys Innova deals with many on-site seminars, the FDA inspection preparation project, and OEM product development, and popularity has been acquired.

Contact Us

Qualys Innova
5-5, 7 Seishin, Sagamihara-shi, Kanagawa, Japan

Mail : mail@qualysinnova.com

  • FDA講習会

    FDA GMP ( QSR ), Design Control Guidance, CAPA, P&PC Process Validation, Software Validation, On-Site Training.

  • FDA査察準備

    The prepare project for accommodating to the FDA inspections.

  • 医療機器開発

    OEM development of Medical Device in Japanese market. / Application to MHLW and testing for application.

  • FDA GMP システム構築

    Establishment of FDA GMP ( QSR )

  • 業務委託

    Outsource of Internal Audit and Supplier Audit. / Any improvement projects based on Six Sigma method.