Our software development process is defined by close collaboration with our clients. We develop software as well for R&D applications as for vitro diagnostics.

We employ agile methods to ensure focused and efficient development. Our approach is both iterative and evolutionary. In order to guarantee the quality and sustainability of our products, we place great emphasis on clear and consistent documentation.

Proven Quality Management

Our software is developed for different workflows with proven quality management. We can produce software ready for ISO 13485 certification.

• Guidelines
  • EU-Directive 98/79/EC, 2007/47/EU, FDA CFR21 part 11, GAMP
  • ISO 13485, ISO 14971, ISO 62304, ISO 62366
• Quality management for software development
  • ISO 9001 certified quality management system
  • Customer audits: ISO 13485, CFR21 part 11, ISO 62304
• Declaration of ISO 62304 conformity
• Experience in realization of
  • CE-IVD certification
  • FDA compliant products
  • ISO 62304 compliant development and documentation

Interactivce software development process

Latest projects of our team

• Genespotter: Standalone program for high-throughput microarray analysis
• CheckReport: System for diagnostic microarray analysis (IVD product)
• JAEGER Reader: Android-based app for lateral flow test cartridge analysis (IVD product)
• MITOVIT: Software for a hypoxia training (altitude training) system