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
We launched the product as planned
Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.
Kasve brought us enourmous Quality Management know-how
Together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.
Credibility for a Start-up with a QMS Certificate
Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.
Contact us
Do you need a qualified partner to support you?
We help healthtech companies succeed in the international market. Leverage our expertise and our comprehensive network!
