Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
Groundwork for success
Our Product Development Health Check is a light, audit-like preliminary evaluation that involves examining the current state of your product development in relation to the requirements set by the Medical device software – Software life-cycle processes standard (EN 62304:2006). The service is highly beneficial, for instance, when a software company that has already established its presence expands its operations to medical software.
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements, and that you will have sufficient resources and the right tools and methods for completing your development project.
Detailed plan for execution
Kasve’s experts familiarise themselves with your activities and processes, and carefully review your current product development documentation. Based on this work, Kasve will prepare a list of observations, and draw up a plan of measures and a schedule for correcting any deviations and failings that may have been detected.
Kasve’s specialists Rosa Tengvall, Mikko Juuti and Nina Vartiainen, also serve as framework agreement consultants of the ELY Centre Business Development Services. This means that the above services are also available as ELY Business Development (Kehpa) Day services!
Our references
With the help of Kasve, we developed a marketable medical device in a year
Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.
Growth requires a quality management system
Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.
A comprehensive partner for the establishment phase
Kasve accompanied the preparation and establishment phase of Neurocenter Finland.
Contact us
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