UDI & Regulatory Affairs
Agnieszka has in-depth knowledge of regulations for general non-active, non-implantable medical devices across anesthesia, respiratory, urology and surgical therapies. Her experience includes developing technical documentation and risk management files, preparing submissions to notified bodies and regulatory agencies, conducting compliance gap analyses. She also has sound experience in developing regulatory strategies and managing cross-functional projects globally.
Agnieszka’s key expertise is in Unique Device Identification and GS1 standards, both in labelling requirements as well as data publication and maintenance of UDI records. Her main activities are developing UDI implementation strategies, primarily for the US and the EU, but also for other regions; developing UDI procedures and supporting procedural alignment across QMS; supporting UDI and Basic UDI-DI assignment; supporting GUDID submissions and data preparation for EUDAMED UDI module. Agnieszka also delivers UDI training courses and workshops.
The key expertise areas of Agnieszka
Unique Device Identification
- GS1 Standards
- Technical Documentation
- Risk Management
- Regulatory Strategy
- Project Management
Agnieszka about working at Qserve
“The one thing that I like the most about Qserve is the practical approach – balancing business needs and regulatory compliance, while maintaining high standard of deliverables. I am excited to engage with customers to create rewarding experiences”.
Agnieszka has a degree in Biomedical Engineering from Cork Institute of Technology in Ireland.
Prior to joining Qserve, Agnieszka worked for 6 years in medical device industry, holding various regulatory affairs positions. She was responsible for regulatory compliance developing technical files, preparing submissions to regulatory bodies and making registration submissions for all the major markets. In her last position, Agnieszka led an international team in implementing GS1 standards to meet FDA and commercial UDI requirements, followed by gap assessment against the requirements of the MDR UDI and establishing implementation strategy to align.
Learn more about our services within Regulatory Affairs