Silicus Medical Device Software Company

Medical Devices.

Industry Expertise.

Medical device industry is experiencing a revolution with innovative medical and medical mobile devices for non-invasive surgeries, wearables, implants, and home diagnostics. Development and deployment of successful medical devices is key to providing best-in-class patient care and services.

Silicus’ medical device practice successfully develops and deploys Class I, Class II, and Class III devices built on regulatory and strategic frameworks that can support both simple and complex requirements to achieve clinical improvements without affecting patient safety. Our design services deliver streamlined, high utility ergonomic products with vast integration capabilities to provide best-in-class services and utility both in the clinic and in the operating room.

We provide diversified software solutions for clinical visualization across five imaging modalities and leverage advanced design documentation techniques to expedite the conformance process and fast track devices for FDA approval and CE Marking.

Our experts are ISO 13485 and 21 CFR Part 11 certified for FDA Conformance and can be deployed, as needed, to get your medical device software approved and into the market quickly.

Medical Device Software Development

Segments We Serve. Our Customer Base.

Medical Imaging & Modalities
Medical Imaging & Modalities

Silicus helps CT, MRI, Fluoroscopy, Ultrasound, PET, Radiology Information Systems, and Hospital Information solution providers with comprehensive DICOM based imaging solutions, including:

  • Image Management
  • Network Image Transfers
  • Network Printing
  • Media Interchange & Archive
  • DICOM validations
Biometrics & Wearables
Biometrics & Wearables

Silicus has expertise working on portable diagnostic monitoring units, lifestyle optimizers, and health check monitors for home and remote diagnostics, integrating sensors, mobile apps and cloud infrastructure into a digital healthcare application. Our expertise includes:

  • Cross platform & hybrid mobile apps
  • IoT – Mobile app integrations
  • Embedded software development
  • Low level programming in C / C++
  • Cloud infrastructure deployments
Medical Care Management
Medical Care Management

Our medical device experts help manage the medical care device lifecycle with prompt delivery of software applications for the intended use of the device. Our expertise includes:

  • Assessment & consulting
  • Design and Architecture
  • User Experience & Interface Design
  • Development and Testing
  • Verification & validation
Point of Care Applications
Point of Care Applications

We work with some of the leading medical point of care solution providers, helping develop apps for medical decision making, differential diagnosis and risk calculation, preventive screening, drug information etc. Our services include:

  • Cross platform & hybrid mobile apps
  • User Experience & Interface Design
  • Data Management & Analytics
Medical Device Software Validation

Build with Confidence. Reliable & Timely Services.

Assessment & Consulting
Assessment & Consulting
  • Feasibility analysis
  • FDA conformance assessment
  • Risk analysis
  • Securing 510K clearance
  • Audit trails and reports
  • ICD 10 billing
Design and Architecture
Design and Architecture
  • Requirements analysis
  • Regulatory body interfacing for clinical approval
  • Object-oriented design
  • Clinical solutions design
User Experience & Interface Design
User Experience & Interface Design
  • Naturalistic clinical interfaces
  • Multi-device user experiences
  • Intuitive clinical workflows
  • Clinical and anatomic visualization
Development
Development
  • Desktop client development for visualization
  • Web-based thin clients
  • PACS integration
Certifications
Certifications
  • ISO 13485, ISO 14971:2007
  • IEC 60601-1
  • FDA 21 CFR Part 820, Part 11
V&V planning
V&V planning
  • Feasibility analysis
  • Software risk analysis
  • Compliance with certification standards
Verification & Validation
Verification & Validation
  • Verification checklists
  • Ground truth measurement validations
  • Validation with software phantoms
  • Validation protocols and tests
  • Develop Design History File (DHF)
Regulatory Compliance Testing
Regulatory Compliance Testing
  • Functional, system, regression testing
  • UI/UX testing for ergonomic interfaces
  • 510K Clearance, ISO 13485 & 60601
  • Post-market surveillance
  • Equipment qualification (DQ, IQ, OQ, PQ)
  • Software design test (DVT)
Software design for Medical Devices

Why Work With Us. Our Track Record.

Class I, II, & III Medical Devices
Class I, II, & III Medical Devices

We design and develop software for Class I, Class II, and Class III Medical Devices with varying complexities and risk stratification, specializing in devices for orthodontics, orthopedics, neurosurgery, cardiovascular, and urology.

Fast Track FDA Conformance
Fast Track FDA Conformance

Our disciplined design control documentation expedites the conformance process for obtaining FDA approval and 510K clearance for devices.