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Scientist in a laboratory working on a computer with data displayed on the screen, viewed from behind.

FDA issues final guidance on Computer Software Assurance in production and quality systems

Katarzyna Wesołowska Członek Zarządu

Tablet displaying text on a desk next to open books in a modern office or research library.

Borderline & Classification Manual 2025 – clarifying MDR/IVDR borderline cases

Katarzyna Wesołowska Członek Zarządu

Close-up of scientists in lab coats writing notes on paper in a research laboratory.

Updated MHRA requirements for clinical investigations of medical devices

Małgorzata Pawlikowska Head of Clinical Study Department

Laboratory with digital cloud network visualization above computers and equipment, symbolizing data connectivity.

Data Act and medical devices: new IoT data-sharing obligations

Izabela Chodara Director of Strategy & Operations

Australian TGA issues guidance on regulating Software as a Medical Device (SaMD)

Katarzyna Wesołowska Członek Zarządu

New restrictions on CMR substances (Carcinogenic, Mutagenic and Reprotoxic) in the EU – Commission Regulation (EU) 2025/1731

Małgorzata Pawlikowska Head of Clinical Study Department

Scientist using a pipette in a laboratory, member of TEAM-NB medical devices association

Strengthening innovation pathways for orphan IVDs under the IVDR: Team-NB advocates regulatory flexibility

Agnieszka Czapko Head of Regulatory & Startup Department

Participant at the 6th Central European Biomedical Congress 2025 in Krakow, standing next to the event banner focusing on neuropharmacology and AI in bioinformatics

In Kraków: The Future of Neuropharmacology and AI in Healthcare

Fryderyk Janiak Business Development Manager

Female doctor with folded arms standing in front of the Swiss flag, representing medical authority and regulation.

Switzerland revises clinical trial documentation requirements – new version of Swissmedic guideline effective June 2025

Małgorzata Pawlikowska Head of Clinical Study Department

Magnifying glass focusing on the abbreviation IVD on a document, symbolizing in-vitro diagnostic scrutiny.

IVD performance studies clarified: MDCG 2025-5 answers 50 frequently asked questions

Izabela Chodara Director of Strategy & Operations

Smiling man in a navy suit and glasses standing in front of AI & MedTech CEE 2025 conference screen showing event date and tech-themed background

AI & MedTech CEE 2025: shaping the future of healthcare AI

Fryderyk Janiak Business Development Manager

Group of four business professionals posing in front of Health Business Innovation 2025 backdrop at the Regional Chamber of Commerce in Katowice

Health Business Innovation 2025 – shaping the future of MedTech in Katowice

Fryderyk Janiak Business Development Manager

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