Medical Devices Software
We develop medical device software (class A, B, C) that fully comply with the international standards IEC 62304, ISO 13485, and ISO 14971. We provide secure and value-added medical software solutions that are based on reliable and secure architecture, robust risk control measures, security audits and penetration testing during and after the development. All patients data are handled according to HIPAA (Health Insurance Portability Accountability Act) and GDPR (General Data Protection Regulation).
Internet of Medical Things (IoMT), real-time health monitoring and data-driven decision-making tools (wireless and bluetooth monitors).
Electronic Medical Records (EMR) solutions that seamlessly integrate with other healthcare software (HL7 or FHIR interoperability).
Software development services according to ISO 60601-1, “Medical electrical equipment – General requirements for basic safety and essential performance” for SiMD.
Medical device software engineering that fully incorporates ISO 82304-1, “Health software – General requirements for product safety” for SaMD.
We rigorously follow software engineering best practices to provide full regulatory compliance and high healthcare software performance as summarised below:
- Engineering requirements elicitation
- Scalable and secure architecture design
- Development and implementation
- Quality assurance (testing and verification)