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Regulatory Affairs Consultation
Consulting content
Consulting list
List of consulting services
-Strategy planning from certification / approval application to insurance acquisition
-PMDA face-to-face advice, interview support with third-party certification bodies
-Support for preparation of approval / certification application
-Investigation of estimated cost of medical device sales
-Investigate medical device type, general name and application category
-Confirmation / advice of catalogs etc. related to medical device advertising regulations
-Examination of necessary materials for QMS conformity assessment
-Education support for personnel in charge of regulatory affairs
The Regulatory Affairs Organization provides regulatory affairs consulting for medical devices.
For any requests or inquiries regarding the above consulting services, please do not hesitate to contact us via telephone or the inquiry page.
To request / inquiry form
Regulatory Affairs Consultation
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Consulting content
List of consulting services of the Regulatory Affairs Organization
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PDMA face-to-face advisory support
Support for the preparation of materials for face-to-face advice implemented by the Medical Devices Agency(PMDA)
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Consulting plan details
Three plans are available for consulting methods, periods and costs