Send your request Join Sii
Send your request Join Sii
Send your request Join Sii

Our key strengths

1000+ experts

from various technologies in healthcare projects

Extensive domain knowledge

Validation, LIMS, Chromatography Systems, EQMS

One-Stop Shop

from engineering solutions, through software development and testing to BI and enterprise software

Complete IT support

for all stages of Life Science Product Cycle

Full product engineering services

for software medical devices, according to IEC 62304 and ISO 13485 standard

Impressive references

from global industry leaders

Meet our experts

Sector-focused solutions 

  • Data Analytics and Data Management
  • Drug Discovery and therapy support
  • Machine learning, Deep learning, AI, NLP
  • Image Recognition and Computer Vision
  • Data visualization
  • Data Science and Decision Optimization
  • Real-World evidence and Real-World data
  • Recommendation systems and analytics

IT professional services for:

  • Enterprise Quality Management Systems (QMS/EQMS)
  • Laboratory Information Management Systems (LIMS)
  • Chromatography data systems
  • Regulatory submission, information & document management tools

 

  • Analysis services for compliance with Standards and Regulations
  • Embedded Firmware & Software development (accordingly to IEC 62304, SiMD)
  • Device Hardware Design and Development
  • Embedded Security Services
  • Embedded testing
  • Implementation & maintenance of ISO and compliance norms to selected standards
  • Cybersecurity for Medical Devices
  • Software in/as Medical Device
  • Risk analysis (accordingly to ISO 14971, IEC 62366)
  • Consulting, constant support, continues improvement
  • Supporting standards: ISO 9001, ISO 27001, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 82304, and regulations: MDR, IVDR
  • Full testing services for projects with GxP/CSV requirements
  • End-to-End Validation Services
  • Tool Qualification and implementation
  • Quality Assurance
  • Continues testing for healthcare
  • Embedded Testing according to IEC 62304
  • Digital Therapeutics and IoT
  • Personalized Health and Mobile Health, custom solutions
  • Health Information Systems (incl. DICOM, HL7, FHIR)
  • Enterprise applications and customization
    • SAP
    • Salesforce
    • Dynamics 365 (incl. Microsoft Cloud for Healthcare)
    • Microsoft 365 (incl. Microsoft Cloud for Healthcare)
    • Atlassian
  • Cybersecurity

 

  • Data quality & document management
  • HR
  • Business consulting
  • Marketing & graphic design
  • Procurement services
  • Payroll & administration
  • Concept study & analysis
  • Production lines design, modifications & upgrades
  • Process digitalization & visualization
  • MES/MOM implementation
  • ERP integration & implementation
  • Firmware / Software development
  • Test & Validation under GxP
Bioinformatics
  • Data Analytics and Data Management
  • Drug Discovery and therapy support
  • Machine learning, Deep learning, AI, NLP
  • Image Recognition and Computer Vision
  • Data visualization
  • Data Science and Decision Optimization
  • Real-World evidence and Real-World data
  • Recommendation systems and analytics
Life Science applications and systems

IT professional services for:

  • Enterprise Quality Management Systems (QMS/EQMS)
  • Laboratory Information Management Systems (LIMS)
  • Chromatography data systems
  • Regulatory submission, information & document management tools

 

Medical & Diagnostics Devices
  • Analysis services for compliance with Standards and Regulations
  • Embedded Firmware & Software development (accordingly to IEC 62304, SiMD)
  • Device Hardware Design and Development
  • Embedded Security Services
  • Embedded testing
ISO and Medical Compliance
  • Implementation & maintenance of ISO and compliance norms to selected standards
  • Cybersecurity for Medical Devices
  • Software in/as Medical Device
  • Risk analysis (accordingly to ISO 14971, IEC 62366)
  • Consulting, constant support, continues improvement
  • Supporting standards: ISO 9001, ISO 27001, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 82304, and regulations: MDR, IVDR
Testing & Validation (CSV)
  • Full testing services for projects with GxP/CSV requirements
  • End-to-End Validation Services
  • Tool Qualification and implementation
  • Quality Assurance
  • Continues testing for healthcare
  • Embedded Testing according to IEC 62304
Digital Therapeutics, IT & Enterprise Software
  • Digital Therapeutics and IoT
  • Personalized Health and Mobile Health, custom solutions
  • Health Information Systems (incl. DICOM, HL7, FHIR)
  • Enterprise applications and customization
    • SAP
    • Salesforce
    • Dynamics 365 (incl. Microsoft Cloud for Healthcare)
    • Microsoft 365 (incl. Microsoft Cloud for Healthcare)
    • Atlassian
  • Cybersecurity

 

Healthcare Business Process Outsourcing (BPO) Services
  • Data quality & document management
  • HR
  • Business consulting
  • Marketing & graphic design
  • Procurement services
  • Payroll & administration
Engineering Services and Smart factory
  • Concept study & analysis
  • Production lines design, modifications & upgrades
  • Process digitalization & visualization
  • MES/MOM implementation
  • ERP integration & implementation
  • Firmware / Software development
  • Test & Validation under GxP

We help clients achieve their goals 

What can we do for you?

See how we support our clients in the medical industry

Industry leaders trusted us

Our case studies prove our expertise

Browse all

Latest news

If you would like to learn more about our solutions contact Iryna

Iryna Seryvko

Managing Director Sii Ukraine

Contact our expert

Iryna Seryvko

Contact our expert

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