EU MDR and CE Marking Roadmap for Neonatal Medical Device

Global Newborn Solutions is seeking a Regulatory Affairs Advisor to guide the CE marking process for the 'Dream Warmer,' a non-electric neonatal warming solution designed for resource-limited settings.

The goal of this project is to develop a comprehensive regulatory package to ensure the lawful and safe deployment of this life-saving medical innovation. The volunteer will work with our team to:

- Conduct an EU MDR classification assessment and determine the applicable conformity assessment route.
- Map the CE marking pathway, covering technical documentation, clinical evaluation, post-market surveillance, vigilance, and Quality Management System (QMS) requirements.
- Create a registration roadmap including estimated timelines, required resources, and key milestones.
- Lead 1-2 knowledge-sharing sessions with our team to ensure the sustainability of the regulatory strategy.

This project will create a clear CE registration pathway for the Dream Warmer, enabling lawful, safe deployment of a non-electric neonatal warming solution (the Dream Warmer) in resource-limited settings. Volunteers will directly support Global Newborn Solutions' mission to advance medical innovations that improve neonatal health and survival.

GNS will engage its team in collaborative knowledge-sharing sessions and work with the volunteer to review device-specific information; specifics and available materials will be provided during interviews. The volunteer will produce a practical roadmap and transferable knowledge the team can use to advance CE registration.