Optimizing Neonatal Nutrition: Regulatory Documentation for Next-Generation Milk Analysis

Important results from the project

The project aimed to produce regulatory documentation for Miris Human Milk Analyzer (HMA), necessary to conduct clinical performance studies and regulatory applications within the EU and USA. The Investigator´s Brochure and Statistical Analysis Plan for planned studies are available as drafts. These will be completed and validated in a later project phase. Study plans and user manuals for study sites have been developed, which meet the regulatory requirements placed on studies for the testing of medical devices intended for the EU and US markets.

Expected long term effects

The result of the project means that Miris is prepared for the planned performance studies, and is ready to make contact with prospective study sites. The work completed also strengthens Miris capacity for future projects and supports the company´s innovation in neonatal nutrition. With the close collaboration with a CRO in this project, valuable knowledge has been passed on to the company, to be used in future work.

Approach and implementation

A clear project formulation and help from an expert consultant meant that the goals and outcome coincided to a very high degree. The work could be carried out efficiently and focused by isolating clear tasks. Beneficial that knowledge that can be used in future projects could be transferred to the company.