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Izabela Chorda and Maciej Dubowik at TUV Nord Conference

Software and legislation and medical devices

“Software in the context of medical device legislation” – this was the slogan of this year’s conference, organized by TÜV NORD...

Maciej Dubowik Regulatory Affairs Associate

Three days at SALMED 2024

– Thanks to the combination of the event with the LABEXPO fair, approximately 300 companies from Poland and abroad and over three thousand visit...

Katarzyna Wesołowska Vice President of the Board

AI ACT abstract image with robot head and European Union flag

AI ACT finally adopted by the EU Parliament

On March 13, 2024, the European Parliament finally adopted the Artificial Intelligence Act (called: AI Act). It is the world’s first comprehensive hor...

Katarzyna Wesołowska Vice President of the Board

Clinical Investigation Plan – MDCG Guidance 2024-3

MDCG has recently released the informative guidance about the content of the clinical investigation plan (CIP). CIP shall set out the objectives, desi...

Katarzyna Wesołowska Vice President of the Board

Second call for EU reference laboratories for high-risk IVDs

EU Reference Laboratories according to the IVDR should be enabled to verify by laboratory testing the performance presented by the manufacturer and th...

Katarzyna Wesołowska Vice President of the Board

What challenges will the medtech industry face in 2024?

Innovations and Development: Medical products typically have a lifecycle of only 18–24 months before a new and improved product emerges. This is just...

Katarzyna Wesołowska Vice President of the Board