News

Pure Clinical at Warsaw Medical Expo

Expert Panels Support for Orphan Medical Devices: EMA’s Pilot Programme

Katarzyna Wesołowska Board Member

Pure Clinical at MEDICA 2024

Report devices and papers

Poland Among Top Global Exporters in Medical Devices and Pharma: Insights from the 2024 Report

Pure Clinical and MDR Regulator at the 4th International Conference “WE! Are the Clinical Research” in Warsaw

Regulatory Status of Ethylene Oxide (EtO) for Sterilisation of Medical Devices: MDCG 2024-13

MHRA: Changes in Post-Market Surveillance of medical devices

Papers on table showing reports

MedTech Europe Report 2024: Insights into Europe’s Medical Technology Sector and Poland’s Role

Invitro process

Transitional provisions for the certification of Class D in vitro diagnostic (IVD) medical devices under the IVDR

Izabela Chodara Head of Clinical Unit | IVD

Asian scientist looking at a microscopic sample of experimental cyan is doing an in vitro vaccine experiment in a science lab

You can give your feedback to EC about the draft of Common Specification for highest risk in vitro diagnostic medical devices!

Adam Sobantka President of the Board

In vitro diagnostic process

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

Izabela Chodara Head of Clinical Unit | IVD

Clinical Evaluation of Orphan Medical Devices: New Guidelines

Marzena Bielińska Clinical Trial Manager | MD

1
2
>

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