MDR EUDAMED project at DG SANTE, EC

Business Analyst

2022-05 - present · Vilnius, Lithuania · Remote

About the system

MDR EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

My role

I turn regulatory requirements, functional requirements and change requests into detailed requirements artefacts and tasks for developers with acceptance criteria. Machine-to-machine (XML/XSD) exchange scenarios are an integral part of almost every change. I align solutions with business and technical stakeholders and support developers and QA throughout implementation and testing. I keep artefacts consistent and traceable across Confluence and Jira.

My area of responsibility has changed over time. I was the sole analyst on the Market Surveillance module and on the Old and Custom-Made Devices (OCM) functionality up to their first release, after which both continued with other analysts. I also delivered the redesign of the Vigilance search, changes in the Certificates module and a wide range of other changes in Vigilance.

Alongside the delivery work I contribute to the team’s analysis methodology, mainly to the use case structure and to the way security permissions are described.