Case Studies

Our experience speaks through real projects. Here we showcase selected cases delivered by the Pure Clinical and MDR Regulator teams – from quality system implementation and medical device certification to clinical investigations and post-market surveillance. Each project demonstrates how we combine regulatory expertise with a deep understanding of product development and clinical practice.

Preparation of Technical Documentation for Class III Substance-Based Medical Devices

This project involved a comprehensive update and adaptation of the technical documentation for two Class III substance-based medical devices —...

PROJECT COORDINATOR Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

Clinical investigation on a novel resorbable medical barrier

This completed clinical investigation evaluated the safety, resorption profile, and clinical performance of a resorbable medical barrier intended to support...

PROJECT COORDINATOR Małgorzata Pawlikowska Head of Clinical Study Department

Post-Market Clinical Follow-up – Long-Term Hemodialysis Catheters

This observational post-market clinical follow-up (PMCF) collected real-world evidence on the safety and performance of a long-term haemodialysis catheter system....

PROJECT COORDINATOR Izabela Chodara Director of Strategy and Operations

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