Marta Kuznicka
Head of Quality and Regulatory
Marta is an expert in medical device regulation, ensuring software solutions meet global compliance standards. She combines deep regulatory knowledge with a passion for technology that drives safer, trusted healthcare innovation.
How we achieved MDR IIb certification: The Infermedica story

How we achieved MDR IIb certification: The Infermedica story

Discover Infermedica’s journey to MDR Class IIb certification. Learn how we navigated the complexities of AI regulation in healthcare, overcame key challenges, and built trust through safety, compliance, and clinical validation.

Not all AI is created equal. We’ve got MDR Class IIb certification.

Not all AI is created equal. We’ve got MDR Class IIb certification.

Building trust in healthcare AI: our Medical Guidance Platform is now MDR Class IIb certified, the highest level for software of its kind.

Regulating AI in healthcare: Fall 2023 observations — Part two

Regulating AI in healthcare: Fall 2023 observations — Part two

An overview of the challenges faced by regulators and the responsibility of manufacturers regarding the regulation of AI in healthcare in 2023.

Regulating AI in healthcare: Fall 2023 observations — Part one

Regulating AI in healthcare: Fall 2023 observations — Part one

Learn about the current regulations for the use of AI in healthcare and discover how the UK, the US, and the EU are taking different approaches.