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About - Medwise Medical devices and Regulatory Affairs consultants

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BIO


Gianluca Garella founder of Medwise AS
About Medwise

Medwise was founded in 2025 with a clear mission: to bring smarter, safer, and more efficient solutions to neonatal infusion therapy serving the Nordic countries.
Building on years of experience of the founders in the medical device industry, our company specializes in the development and manufacturing of custom-made infusion sets designed specifically for neonatology units.
At the heart of Medwise is a deep understanding of hospital workflows and patient safety — the result of decades of hands-on collaboration with healthcare professionals.
Every Medwise solution is engineered to minimize infection risks, reduce handling errors, and streamline daily routines, ensuring both optimal care for newborns and greater efficiency for medical staff.
Medwise was established under the leadership of Gianluca Garella, already Managing Director of Neomedica s.r.o., a company recognized for distributing high-quality medical devices to hospitals across Central Europe, based in Slovakia. With extensive experience in the hospital supply chain, regulatory frameworks, and clinical applications,
Gianluca with his Italian temperament brings a strategic vision focused on innovation, reliability, and partnership.
Key pillar of Medwise’s strength is Tatiana Garella, who brings extensive experience in Regulatory Affairs to the company.
Having worked as a Regulatory Affairs Manager for major multinational medical device manufacturers, Tatiana has developed a deep understanding of EU regulations, conformity assessment, and market access strategies. At Medwise, she leverages her vast knowledge to support both distributors and manufacturers in navigating the complex EU regulatory landscape, with a particular focus on the Slovak and Czech markets.
Through Medwise, this expertise has evolved into a genuine commitment to improve patient care.
Medwise stands for safety, intelligence, and trust — in every drop delivered.

Vestre Strømkaien 7 - 5008 Bergen - NORWAY
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