Pure Clinical

News

29/09/2025

Medbaltica 2025: Exploring Innovation in Riga

Fryderyk Janiak Business Development Manager
Scientist in a laboratory working on a computer with data displayed on the screen, viewed from behind.
25/09/2025

FDA issues final guidance on Computer Software Assurance in production and quality systems

Katarzyna Wesołowska Członek Zarządu
Tablet displaying text on a desk next to open books in a modern office or research library.
23/09/2025

Borderline & Classification Manual 2025 – clarifying MDR/IVDR borderline cases

Katarzyna Wesołowska Członek Zarządu
20/09/2025

Pure Clinical and MDR Regulator at GMES 2025 in South Korea

Katarzyna Wesołowska Członek Zarządu
Close-up of scientists in lab coats writing notes on paper in a research laboratory.
16/09/2025

Updated MHRA requirements for clinical investigations of medical devices

Małgorzata Pawlikowska Head of Clinical Study Department
Laboratory with digital cloud network visualization above computers and equipment, symbolizing data connectivity.
15/09/2025

Data Act and medical devices: new IoT data-sharing obligations

Izabela Chodara Director of Strategy & Operations
29/08/2025

Australian TGA issues guidance on regulating Software as a Medical Device (SaMD)

Katarzyna Wesołowska Członek Zarządu
12/08/2025

New restrictions on CMR substances (Carcinogenic, Mutagenic and Reprotoxic) in the EU – Commission Regulation (EU) 2025/1731

Małgorzata Pawlikowska Head of Clinical Study Department
Scientist using a pipette in a laboratory, member of TEAM-NB medical devices association
28/07/2025

Strengthening innovation pathways for orphan IVDs under the IVDR: Team-NB advocates regulatory flexibility

Agnieszka Czapko Head of Regulatory & Startup Department
Participant at the 6th Central European Biomedical Congress 2025 in Krakow, standing next to the event banner focusing on neuropharmacology and AI in bioinformatics
24/07/2025

In Kraków: The Future of Neuropharmacology and AI in Healthcare

Fryderyk Janiak Business Development Manager
Female doctor with folded arms standing in front of the Swiss flag, representing medical authority and regulation.
27/06/2025

Switzerland revises clinical trial documentation requirements – new version of Swissmedic guideline effective June 2025

Małgorzata Pawlikowska Head of Clinical Study Department
Magnifying glass focusing on the abbreviation IVD on a document, symbolizing in-vitro diagnostic scrutiny.
19/06/2025

IVD performance studies clarified: MDCG 2025-5 answers 50 frequently asked questions

Izabela Chodara Director of Strategy & Operations
Our work

Case study

Clinical Performance Evaluation of HIV-1 RNA Kit

Efficacy and safety evaluation in clinical trial of dermal filler

Clinical performance of HIV Ag/Ab diagnostic test

Clinical performance study of SARS-CoV-2 & influenza A/B antigen test
More case studies