Medical Devices Software

Medical Devices

We develop medical device software (class A, B, C) that fully comply with the international standards IEC 62304, ISO 13485 (Quality), and ISO 14971 (Risk). 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.

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.

All patients data are handled according to PIPEDA/PHIPA (Personal Information Protection and Electronic Documents Act / Personal Health Information Protection Act), HIPAA (Health Insurance Portability Accountability Act), and GDPR (General Data Protection Regulation). We rigorously follow software engineering best practices to provide full regulatory compliance and high healthcare software performance as summarised below (toggle for more details):

  1. Planning
  2. Requirements
    • Risk control (Failure Mode, Effects, and Criticality Analysis (FMECA) and threat modelling)
    • Software of unknown provenance (SOUP) or off-the-shelf software items, legacy software, and security
    • Traceability
  1. Architectural design
    • Transform requirements into architectures
    • Design architecture for the interfaces of software system and/or item(s)
    • Identify segregation necessary for risk control
  2. Detailed design (each unit, interfaces)
  1. Implementation (peer reviews, code analysis, conformance with coding conventions)
  2. Integration (assemble software units into items and items into a software system)
  1. Integration testing (confirm that all units and items are assembled without errors)
  2. System testing
  3. Software release document