Agustina Susott

Agustina is a Regulatory Affairs consultant who has collaborated in multiple product registrations spanning the medical device, diagnostics, and pharmaceutical industries. In 2018, she founded a Regulatory consulting group that later grew to become Suma Medtec, offering comprehensive services to companies wishing to market their products globally.

Agustina began her career in the United States with a focus on first-time registrations and renewals for implantable vascular devices, and later expanded the scope of her work to include surgical products, imaging equipment for vascular access, in-vitro diagnostics, combination products for drug delivery, and SaMD in the USA, EU, Canada, Australia , LATAM, and APAC regions.

​Her expertise beyond Regulatory Affairs includes quality management system implementation, change management, new product development, audit preparation, and post-market compliance.