Blog

Izabela Chodara and Maciej Dubowik at TUV Nord Conference

Our delegation at the TÜV NORD Polska conference

Another interesting event is behind us. This time, on Tuesday (March 26), representatives of MDR Regulator and Pure Clinical participated in an intere...

Katarzyna Wesołowska Vice President of the Board
Delegation at Salmed Conference

Three days at SALMED 2024

For three days (from March 19 to 21), our delegation participated in the International Trade Fair of Medical Equipment and Instruments SALMED 2024...

Katarzyna Wesołowska Vice President of the Board
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
Delegation at SALMED

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
Abstract image of clinical Investigation Plan – MDCG Guidance -2024-3

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

A year in our industry and our company

We’ve had a very interesting and intense year in our industry, so it’s time for a little summary! Here’s what’s worth remember...

Katarzyna Wesołowska Vice President of the Board