Optimizing Neonatal Nutrition: Regulatory Documentation for Next-Generation Milk Analysis
| Reference number | |
| Coordinator | Miris AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | January 2024 - August 2024 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses 2023 |
Purpose and goal
The main purpose of this project is to develop comprehensive regulatory documentation for Miris´s Human Milk Analyzer (HMA) to facilitate its commercialization in both the EU and US markets. The goal is to ensure that HMA meets all the necessary regulatory requirements, which is crucial for enhancing Miris’ capacity for future projects and supporting the company’s innovation in neonatal nutrition.
Expected results and effects
Expected outcomes include the successful commercialization of HMA, which will strengthen Miris´s position in the global market. The project aims to ensure that HMA becomes a reliable tool in neonatal care, potentially leading to better health outcomes for prematurely born infants through more precise breast milk nutrition.
Planned approach and implementation
The project involves collaboration with specialists to produce the necessary documentation required for regulatory approvals in the EU and USA. This includes developing detailed plans for clinical studies and ensuring that all documentation meets high regulatory standards. The implementation of the project also focuses on continuously improving the HMA based on user feedback and current research.