At SANRUBIO Medical Devices Consulting, we help you to have your quality management system ready in accordance with the regulations required by the corresponding health authorities:
task_alt Medical Device Quality Management System (ISO 13485)
task_alt Single Audit Program for Medical Devices (MDSAP)
task_alt Regulation 21 CFR 820 (FDA)
task_alt Good manufacturing practices, Provision 3266/2013 (ANMAT)
OUR SERVICE INCLUDES:
task_altEvaluation of the current Quality Management System.
task_altDesign and development of a new Quality Management System according to requested regulations.
task_altAction plan to cover identified gaps.
task_altInternal audits (virtual or in-situ).
OUR TEAM OF PROFESSIONALS IS READY TO HELP YOU
