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About Us

Agustina Susott

Managing Director

Global Regulatory Affairs and Quality

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.

Gregory Susott

Director

Engineering and Portfolio Development

Gregory is a medical device consultant with over 15 years of experience taking products from concept to market. His work in development engineering and project management has contributed to multiple global launches within product categories that include vascular access, parenteral drug delivery, interventional radiology, critical care, and implantable devices. 

 

Prior to co-founding Suma Medtec, Gregory held various functional and leadership positions in the US and EU while with Novartis, Becton Dickinson, Johnson & Johnson, and Cook Medical. As a managing partner and consultant, Gregory now collaborates with organizations of all sizes, providing the resources and strategic planning they need for successful development phase closure and commercialization.

Suma Medtec was founded with a vision to enable innovative collaborations toward a better future of healthcare.

Our team applies this to everything we do - it’s inherent to our culture.

GLOBAL & GROWING

We take pride in the global presence of our consultants and development partners, helping meet the needs of any project.

Ready to find out more or request services?

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