Following the 3rd evaluation of the PTTI, Critical Software will receive funding for a feasibility study for transferring methodologies defined in space-specific quality and technical standards, namely the European Cooperation for Space Standardization (ECSS) standards, to the Medical Devices (MD) domain. The goal is the transfer of competences and technologies for a more efficient certification process of a MD. This is vital to the success of start-ups and small companies due to investment capabilities and a significant knowledge gap on how to accomplish MD certification.
The objective of this feasibility study is to cross-analyse space and MD standards and to build up general methodologies for the certification of a MD leveraging on space-recommended approaches. Finally, these methodologies will be used on a real case study of a start-up company that is seeking to qualify a product as a MD.