We run development projects according to the Design Control procedure in our certified Quality Management System. In our Project Handbook we have defined the project organisation, the project phases, the prototypes developed, and the level of documentation required.
All projects start with a feasibility study followed by a proof of concept phase. This is concluded with a proof of concept report, a system requirements specification and plans for the rest of the project.
During the development of the new product, each phase will lead to the development of increasingly sophisticated prototypes and produce the documentation proving their functionality. Finally, the pilot phase leads to the production of the 0-series of the new product.
The transfer of the new product into production is integrated in the overall project in order to make the transition as smooth as possible. Hence only a short maturing phase is necessary after production of the 0-series, before starting up full scale production on validated production equipment.
Verification, validation, documentation, and certification is carried out to the desired level, and in accordance with the relevant regulatory requirements. As Unisensor is certified according to ISO 9001 and ISO 13485, we are capable of developing and producing products at any level of required documentation.