MEDICAL DEVICE REGULATORY CONSULTING
We are a group of specialists with experience in regulatory aspects and registration of medical devices with the health authorities in United States and Argentina.
We are a group of specialists with experience in regulatory aspects and registration of medical devices with the health authorities in United States and Argentina.
SANRUBIO Medical Devices Consulting, offers specialized regulatory consulting services for the registration and maintenance of medical devices before the health authorities in United States (FDA) and Argentina (ANMAT).
In a business where quality and safety come first, we have the necessary tools to overcome any challenge.
01
Service designed to carry out a preliminary regulatory evaluation of your medical device before starting a registration process with the health authorities.
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02
We accompany you throughout the process of registering your medical devices with the health authorities in United States and Argentina.
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03
We adapt your Quality Management System to comply with the regulations required by the health authorities (ISO 13485, MDSAP, BPF, 21 CFR 820).
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04
We offer you the US AGENT in the United States so that you can comply with the requirement established by the FDA for foreign manufacturers.
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OUR TEAM OF PROFESSIONALS IS READY TO HELP YOU
