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.
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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Quality Management Systems in the Health Industry
Kasve will help you build a quality management system that suits your organisation’s operations and supports your business in the optimal way.
Software Development Tools
A turnkey solution for project and knowledge management in medical software product development. The Medical Device Project Management Kit is based on widely used tools.
Outsourced Software Development Project Manager
Kasve’s Software Development Project Manager ensures that your software development is proceeding with a goal-oriented and systematic approach.
Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
IEC/EN 62304 Workshops and Training
The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.
With us, you will gain access to highly experienced specialists in regulatory affairs and their competence related to various regulatory challenges, such as obtaining a CE marking or FDA approval.
Outsourced Quality Manager
Using an outsourced Quality Manager or a person responsible for regulatory compliance will provide more flexibility and free your organisation’s resources to its core activities.
Quality Management System Audits and Evaluations
Kasve’s service range includes internal audits which help you conform to a specific standard, and evaluations and plans that enable you to update your system to meet new requirements.
Outsourced Business Development Manager
Kasve enables its clients to prepare for entering the international market or expand their activities without a need to commit to permanent staff. Kasve’s clients gain access to a highly experienced specialist for the time and extent you need.