Case Studies

The institution responsible for regulating medical devices in the United Kingdom is the MHRA. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person (UKRP).

Clinical Evaluation of Class III Vascular Implants – Transition from MDD to MDR

The authority responsible for regulating medical devices in the United Kingdom is the MHRA. If the manufacturer is based outside...

PROJECT COORDINATOR Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

Usability Study of an Inhaler

The purpose of the usability study was to evaluate whether the interface of a newly developed inhaler allows for safe...

PROJECT COORDINATOR Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

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

This study evaluated the clinical performance of the SARS-CoV-2 & Influenza A/B Antigen Test under conditions of use of the...

PROJECT COORDINATOR Małgorzata Pawlikowska Head of Clinical Study Department

Clinical performance of HIV Ag/Ab diagnostic test

This study evaluated the clinical performance of the HIV Ag/Ab diagnostic test, designed for the qualitative detection of HIV p24...

PROJECT COORDINATOR Izabela Chodara Director of Strategy and Operations

Efficacy and safety evaluation in clinical trial of dermal filler

This study assesses the efficacy and safety of the dermal filler for treating medium facial lines, including nasolabial folds and...

PROJECT COORDINATOR Małgorzata Pawlikowska Head of Clinical Study Department

Clinical Performance Evaluation of HIV-1 RNA Kit

This study assessed the diagnostic specificity and sensitivity of a new in vitro diagnostic device, the HIV-1 RNA Quantitative Diagnostic...

PROJECT COORDINATOR Izabela Chodara Director of Strategy and Operations