Suma Medtec

medical devices

About

Suma Medtec GmbH is a life science consulting company located in Kufstein, Austria. Founded in 2018 by Agustina Susott, the company specializes in supporting manufacturers of medical and pharmaceutical products throughout the product development and commercialization process. Suma Medtec offers personalized services to help clients navigate complex regulatory environments and successfully bring their products to global markets. The company provides a wide range of specialized services, including regulatory affairs, project management, quality management, risk management, and design controls. Suma Medtec assists clients in developing regulatory strategies, managing submissions for certifications, and ensuring compliance with international standards. Their multilingual team has expertise in various regions, including the United States, Europe, Canada, Latin America, Japan, Australia, and New Zealand, enabling them to facilitate market access for their clients.

Technologies

Outlook Microsoft Office 365 Google Cloud Hosting Wix Mobile Friendly Varnish

Keywords

combination products quality management system rd design controls risk management medical devices regulatory affairs human factors latam ce marking fda medical equipment manufacturing regulatory strategy regulatory consulting project management compliance services other scientific and technical consulting services audit support regulatory process product registration regulatory guidance fda pathways regulatory inspection region-specific regulation eu mdr design transfer product development support regulatory risk mitigation regulatory submissions

Location

Kufstein, Tyrol, Austria

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