Hello, my name is Marcelo Antunes, and i help medical device manufacturers in subjects such as risk management, quality system and regulatory affairs in general.
My focus is on a risk management based, lifecycle approach to medical devices regulations to help my clients speed up their regulatory processes to enable quick time to market of their devices.
I offer several solutions which enable medical devices to get to market as quickly as possible, while still conforming with all applicable regulatory requirements which they need to fulfill, including compliance with standards and regulations worldwide.
Medical device registration in Brazil (ANVISA) is one of them.
I offer a varied number of training courses to medical device manufacturers and other interested organizations, including quality system, risk management, IEC 60601 third edition and regulatory affairs training.
