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News
30/05/2025
MedTech Europe calls for 4 urgent systemic changes to MDR/IVDR
Adam Sobantka
President of the Board
29/05/2025
Pure Clinical at the 11th “Clinical Trials Are for You” Conference
Fryderyk Janiak
Business Development Manager
17/05/2025
LifeScience4EU Conference 2025 – wrapped up!
Fryderyk Janiak
Business Development Manager
15/05/2025
FDA Q-Submission Program – Comprehensive guide for medical device manufacturers
Izabela Chodara
Director of Strategy & Operations
27/04/2025
EMA Reflects on Real-World Data in Non-Interventional Studies for Regulatory Use
Adam Sobantka
President of the Board
16/04/2025
BKWM 2025: as a Participant and Sponsor
Katarzyna Wesołowska
Board Member
10/04/2025
Clinical Investigations of Medical Devices in the UK – Updated MHRA Requirements
Ilona Korczak-Cegielska
Director of Clinical & Regulatory Operations
25/03/2025
HealthData@EU – European Commission Launches Central Health Data Platform
Izabela Chodara
Director of Strategy & Operations
19/03/2025
Our Delegation at LABS EXPO 2025 in Poznań
Katarzyna Wesołowska
Board Member
18/03/2025
Joint Discussion Paper – Future Governance of Medical Technologies in the EU
Adam Sobantka
President of the Board
13/03/2025
Remote, but Intense at Health Days 2025
Katarzyna Wesołowska
Board Member
25/02/2025
CIPS Pilot Program – Coordinated Assessment of Clinical Investigations in the EU
Ilona Korczak-Cegielska
Director of Clinical & Regulatory Operations
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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
