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