Unisensor use a generic project model for developing new devices as described in our Project Handbook. The model covers all phases from idea to finished product - ready for production. Unisensor posses all the required and certified skills for developing high quality life science products.
Development projects usually begin with a feasibility study ending up with a proof of concept report. These activities are conducted in our research department and are not a part of the actual development project.
The development project starts with the appointment of a project manager. The project is based on a system requirements specification and a master plan. The master plan will specify a number of phases and major milestones, usually including the development of one of more prototypes. 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.
Unisensor can produce the new product too. Read about it here.
Depending on the requirements we document and validate the development of the new product according to regulatory requirements. We are certified according to ISO 9001 and ISO 13485, and follow cGMP and FDA regulations and guidelines, when required. Read more about our Quality Management System here.