Software Development Tools
The Medical Device Project Management Kit designed by Kasve is a turnkey solution for managing a medical software product development project and related knowledge management.
Agile product development
The Medical Device Project Management Kit designed by Kasve is a turnkey solution for managing a medical software product development project and related knowledge management. It is based on the widely used Jira and Confluence software by Atlassian, whose features have been expanded with selected add-ons, configurations and content to ensure that they correspond with the regulatory requirements set for medical devices. The tools are always tailored to the client, taking into account the special characteristics of the client and client’s products.
Knowledge Management Environment
Use the service and your product development will be supported by a project and knowledge management environment in which:
- The documentation structure is easy to manage and well-documented
- Access rights and management have been determined in a way that supports daily activities and ensures data secure operation
- Automatization of tools and workflows is fully utilised to ensure effective day-to-day activities
- The requirements of standard EN 62304:2006 are fulfilled
- The requirements for tools of standard EN 13485:2016 are fulfilled
- The requirements for product risk management of standard EN 14971:2019 are fulfilled
- Based on your specific needs, the best add-ons have been selected for project management and documentation tools, and these are fully utilised.
- The management of the product development project is seamlessly integrated into your company’s quality assurance system.
Our references
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.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
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.
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