Marta Kuźnicka in

Marta Kuźnicka

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Head of Quality & Regulatory at Infermedica
📍 Warsaw, Mazowieckie, Poland

Marta Kuźnicka is a regulatory expert with over 10 years of experience in the medical technology industry, specializing in AI and Software as a Medical Device (SaMD). She focuses on delivering safe, compliant solutions under MDR, FDA, and ISO 13485 standards. Marta holds a Master of Laws from Uniwersytet SWPS and teaches compliance at Lazarski University.

Interesting fact: Marta led a team to achieve MDR Class IIb certification for an AI-based medical device in just four months with zero nonconformities.

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Experience
10 Years
Current Role
Head of Quality & Regulatory
Job Level
Mid-senior
Location
Warsaw, Mazowieckie, Poland
Personality Overview

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Priorities

Topics Marta cares about

AI Medical Device Regulation
She develops regulatory strategies for AI and LLM-based systems, navigating complex requirements from the EU MDR, FDA, TGA, and the upcoming AI Act.
Efficient Compliance
She emphasizes achieving certification "at speed, " highlighted by her success in securing MDR Class IIb certification in four months, a process she aims to streamline for others.
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Career

Work history

12-2020
Head of Quality & Regulatory
Infermedica
3-2020
Independent Advisor: SaMD & AI medical devices
Self-employed
8-2015 - 12-2020
Head of Regulatory&Quality
AioCare
In the press

Media appearances

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Education
Master of Laws - LLM
Uniwersytet SWPS
Postgraduate studies
Uczelnia Łazarskiego w Warszawie
Social presence
in
Behavioral profile

DISC profile (public)

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