omni
aacc

Company Established In
2013

COMPANY INFORMATION

EMPLOYEES
101-250

HOURS OF OPERATION

8am - 5pm PST

CATEGORIES & HEADINGSdetails >>

Association badge legend
VS Vendor Showcase

sponsored

SMEDIX Inc. is a global software development company focused solely on partnering with healthcare companies to enhance patient care through innovative software solutions and technologies. We help companies bridge the development gap, enabling our customers to effectively commercialize innovative IVD products in a regulated environment. We have the IVD experience and the insight to bring Medical Software Products to market that meet the safety, quality and usability attributes required in the healthcare industry. We can often do it faster and at a lower cost given our global presence, agile methodology and fewer project personnel resulting in efficient project execution with high quality and at a lower cost.

OUR VISION: TRANSFORM PATIENT CARE BY DELIVERING LEADING-EDGE SOFTWARE SOLUTIONS

OUR MISSION: ACCELERATE INNOVATION IN HEALTHCARE THROUGH PARTNERSHIPS TO BRING HIGH-QUALITY SOFTWARE SOLUTIONS AND TECHNOLOGIES TO MARKET

SERVICES:
-SOFTWARE DEVELOPMENT: SW Architecture | Application Software | Cloud Solutions | User Interfaces
-SOFTWARE VERIFICATION & VALIDATION: Test Planning / Development & Execution | Test Automation | V&V Reporting / Results | Tool Validation | SOUP / COTS Validation | Unit / Integration / Functional / Performance Testing
-PRODUCT COMPLIANCE / PROCESS DEVELOPMENT: IVD / FDA 510(k) & PMA / CE Mark: IEC-62304 Standards | Cybersecurity Guidance | ePHI / HIPPA | Quality Management Systems (QMS)
-PROJECT MANAGEMENT: Agile / SAFe | Customized Metrics Reporting | Technical Leadership
-SYSTEMS ENGINEERING: Product Architecture/System Analysis/Trade-Off Studies | Safety/Technical Risk Analysis | Requirements Engineering | Dependency Analysis between software, firmware, hardware, and assay subsystems |Continuous Integration (Dev Ops)
-INTEROPERABILITY: Laboratory Information Management (LIS) Integration | Remote Diagnostics / Support | Cloud Computing
-DATA ANALYTICS: Bioinformatics | Artificial Intelligence / Machine Learning | Epidemiology Reporting
-GLOBALIZATION & LOCALIZATION: SW Translation Integration & Design | Translation Testing

PRODUCTS:
-SMEDIX LIS SOLUTION
-SMEDIX REMOTE DIAGNOSTICS SOLUTION

Vendor Showcase

Smedix

Smedix

SMEDIX Inc. is a global software development firm focused solely on partnering with healthcare companies to enhance patient care through innovative software solutions and technologies. We help companies bridge the development gap, enabling our customers to effectively commercialize innovative IVD products in a regulated environment.

SMEDIX has a very strong team of 120+ engineers with medical software / bio-tech experience and have been successfully helping medical device / healthcare companies meet aggressive deadlines with quality output across all phases of the Software Development Lifecycle (Development, V&V, Compliance and Regulatory Submissions).

See how our software services and products can benefit your project. https://www.smedix.com
read more