Electronic quality management system – eQMS
An efficient, easy-to-use and modern quality management system for a medical device manufacturer.
Reliable eQMS
We have delivered the system for tens of customers both in Finland and elsewhere in Europe. The system is built on Atlassian platform in Jira and Confluence, which ensures affordable pricing and trustworthy maintenance.
Document templates
Our document template package provides a comprehensive basis for a quality management system. In the package, templates for a Quality manual, standard operating procedures (SOPs), forms and registries are included. It is an up-to-date and a high quality package that has been built for years.
Versatile and compliant document environment
The system includes:
- Document approval workflow
- User roles
- Document history
- Traceability and change control
- Ready platform and structure for the whole quality management system.
Our expert services provide assistance also for content creation.
Quality management processes as part of the eQMS functions
We tailor the quality management system electronic processes like CAPA and customer feedback processes based on the customer need. Electronic processes ensure effective, easy to use and reliable operations for the core functions of the quality management.
We build also on top of the same platform an electronic development environment, where the medical device design and development is handled according to the requirements all the way from the product idea to the product launch and maintenance.
Free demo
We are happy to arrange a demonstration of the system for you. Please contact us and ask for a free demo!
Our references
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
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.
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.
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!
