At SANRUBIO Medical Devices Consulting, we have a team of professionals ready to provide you with the best advice and support during the registration process of your medical device, we can guide you in the registration process of your medical devices in UNITED STATES, BRASIL and ARGENTINA.
OUR SERVICE INCLUDES:
task_altEvaluation of the medical device to determine its class.
task_altDefinition of regulatory strategy for the registration of the medical device before the corresponding health authority.
task_altList of documents and specific information of the product that will be required for the presentation before the corresponding health authority.
task_altEvaluation of supporting documentation.
task_altMedical device regulatory compliance status report.
task_altPreparation and submission of the file to the corresponding health authority or certification body.
task_altExplanation and analysis of the results received by the corresponding health authority or certification body.
task_altSupport for resolution of additional requests if this occurs.
task_altBe the regulatory link between your company and the corresponding health authority or certification body.
OUR TEAM OF PROFESSIONALS IS READY TO HELP YOU
