Purpose and goal
The project´s aim is to strengthen Domeject´s competence to develop and commercialize ReDosa™, an innovative syringe for climate-smart healthcare. The goal is to provide external expertise in MDR, ISO 13485 and market strategy to establish a regulatory path towards CE marking, strengthen quality work and develop a strategy for market introduction in Sweden and the Nordic countries.
Expected effects and result
The project is expected to result in a regulatory strategy for CE marking according to MDR, a quality system structure according to ISO 13485, and a plan for verification testing and clinical evaluation. The project will also develop an initial marketing and commercialization strategy. In the long term, ReDosa™ is expected to contribute to reduced plastic waste, increased circularity, and reduced emissions in healthcare.
Planned approach and implementation
The project is carried out together with external experts in MDR, ISO 13485 and market strategy to develop regulatory strategy, structure quality systems and analyze market and procurement processes. The work is carried out through regular working meetings, workshops and joint development of documentation and strategies to ensure knowledge transfer to Domeject.
The project description has been provided by the project members themselves and the text has not been looked at by our editors.
