Changes in the Investigator’s Brochure content – MDCG 2024-5 The revised guidance emphasizes the importance of the Investigator’s Brochure (IB) as part of the required documentation, providing technical and clin...
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
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
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 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
