Get to know our new laboratory! This is another important news from the life of our group! Before the May weekend, our laboratory in Słupsk moved to an absolutely new, very spacious...
Our team during Conference on Polymers The 5th National Scientific Conference on Polymers in Medicine is Behind Us!... Katarzyna Wesołowska Vice President of the Board
26 May 2024 was the last call to apply for MDR for legacy devices and take advantage of the transitional periods 26 May 2024 was the last call to submit an application for MDR for legacy devices and take advantage of the transitional periods! The first condition...
European Health Data Space (EHDS) The European Parliament's adoption of the European Health Data Space (EHDS), gives a significant step towards establishing a resilient European Health...
Information from Swiss Medtech on placing on the market During the shift from MDD to MDR, MDD-compliant devices can only be introduced into the Swiss market until a specified date. Consequently, there's a p... Emilia Geszczyńska Project Manager
Adam Sobantka Lectures at AGH Adam Sobantka, President of Pure Clinical, had the privilege of delivering a lecture on the clinical trials of medical devices at the AGH University o...
Our representatives during the BKWM Conference It was an intense but very valuable time. This week, the delegation from MDR Regulator and Pure Clinical participated in the 2nd National Conference d... Katarzyna Wesołowska Vice President of the Board
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