Blog

Doctor in an abstract image with health icons in circle

Regulation (EU) 2024/1860- the latest changes to MDR and IVDR

On 9 July 2024, regulation (EU) 2024/1860 was published regarding a gradual roll-out of Eudamed, the obligation to inform in case of interruption or d...

Agnieszka Czajkowska
In vitro diagnostic process

MDCG 2020-16 Rev.3- updated IVDR classification guidelines

The Medical Device Coordination Group (MDCG) has published the third version of the MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnos...

Clinical Evaluation of Orphan Medical Devices: New Guidelines

The new guidelines introduced by the European Commission address the clinical evaluation of orphan medical devices under the MDR, recognizing their un...

Guiding Principles for Transparent Machine Learning in Medical Devices

The FDA, Health Canada, and the UK's MHRA have established guiding principles to enhance transparency in machine learning-enabled medical devices (MLM...

Katarzyna Wesołowska Vice President of the Board

Webinar Announcement: Financing Conformity Assessment for Medical Devices

On June 13th (Thursday) at 12:00 PM, we invite you to a free industry webinar with consultations, organized together with Frontline Biosciences S.A...

Katarzyna Wesołowska Vice President of the Board

Participation in the International Clinical Trials Day Conference

Yesterday, our colleagues Katarzyna Szatraj, PhD and Ilona Korczak-Cegielska attended a very interesting conference on the occasion of International C...

Our Representatives at the International Clinical Trials Day Conference

Yesterday, our colleagues Katarzyna Szatraj, PhD and Ilona Korczak-Cegielska attended a very interesting conference on the occasion of International C...

Katarzyna Wesołowska Vice President of the Board

CEOs of MDR Regulator and Pure Clinical Attend Kapitał Na Zdrowie Conference

Today, Katarzyna Wesołowska and Adam Sobantka, the CEOs of MDR Regulator and Pure Clinical, are participating in the very interesting Kapitał Na Zdrow...

Katarzyna Wesołowska Vice President of the Board
Entrance to Pure Clinical Lab in Słupsk

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...