Marta Kuźnicka

Sharpshooter
DISC Type : CD

Head of Quality & Regulatory at Infermedica

Warsaw, Mazowieckie, Poland

Overview

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.

Personality Overview

Thorough Evaluator

Rigorous & Demanding

ROI Driven

They are less concerned about the product and more about its potential impact.  They respond better to strong and respectful interactions. They like to stay in control of the negotiation or defining of the terms.

Topics They Care 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.
Quality Management Systems
Specializes in designing and scaling ISO 13485-compliant Quality Management Systems for global markets, including the EU, UK, Australia, and the US.

Media Appearances

Marta has no verified media appearances

Work History

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

Education

Master of Laws - LLM from Uniwersytet SWPS
Postgraduate studies from Uczelnia Łazarskiego w Warszawie

More Information

Social Presence :

Prographics :

Exp : 10 Location : Warsaw, Mazowieckie, Poland Job Level : Mid-senior Designation : Head of Quality & Regulatory at Infermedica
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Insights For Selling To Marta

During A Call Or A Meeting

DO's

  • Speak about competitive differentiation that your product offers
  • Make sure that you circle back fast on any action items, it wins their trust
  • Refer to testimonials from well-known industry leaders

DONT's

  • Do not hesitate from asking counter questions, just avoid challenging their authority
  • Don’t be in a rush to invite them for a social meet and greet
  • Do not back off when challenged, respond with a confident, objective answer instead

When Cold Calling

When Writing An Email

While Negotiating & Closing

    The secret to closing fast with Marta is

  • Conviction around the impact matters the most to them, followed by a sense of achievement and ROI.
  • Will you ever get a clear answer from Marta

  • If they decide not to use your product, they will say no clearly.

Insights For Deal Planning

    How fast (or slow) will Marta move?

  • If convinced, they can reach decisions quite fast.
  • Can Marta take some risk or not?

  • They do not shy away from taking risks, but can be quite binary about them.

You And Marta

Personality Compatibility


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