Isha’s GMP Consultancy is having experienced partners in various countries which can help your company to access the growing global medical devices market. Our expert team will do a conformity assessment for various device types.
Assess the local regulatory body and the registration requirements for your device.
Review of the technical file to ensure compliance.
Assistance with compilation or review of clinical survey.
Application submission and handling of queries.
Post market obligations
Authorised representative service for specific country.