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.
Segments We Serve. Our Customer Base.
Silicus works with providers for home diagnostics for diagnostic devices, monitoring equipment and therapy delivery as relates to:
- Diagnostic evaluation kits
- Clinical measurement kits
- Test Kits
- Collection kits
Silicus has experience working on portable diagnostic monitoring units, lifestyle optimizers and health check monitors for diagnostics in terms of wearable devices in the form of:
- Activity tracking bands
- Smart watches
- Wearable glasses
- Pain management devices
Silicus works with CT, MRI, Ultrasound, PET, fluoroscopy and Radiology information systems to provide comprehensive imaging capabilities including solutions for:
- Imaging scanners
- Interventional imaging
- Image guided therapeutics
- Imaging Analytics
Invitro diagnostic devices
Silicus works with invitro diagnostic devices for providing diagnostic solutions, measurement of abnormality and delivery of therapeutic solutions as relates to:
- Diagnostic devices
- Monitoring devices
- Compatibility devices
Build with Confidence. Reliable & Timely Services.
Assessment & Consulting
- Feasibility analysis
- FDA conformance assessment
- Risk analysis
- Securing 510K clearance
- Audit trails and reports
- ICD 10 billing
Design and Architecture
- Requirements analysis
- Regulatory body interfacing for clinical approval
- Object-oriented design
- Clinical solutions design
User Experience & Interface Design
- Naturalistic clinical interfaces
- Multi-device user experiences
- Intuitive clinical workflows
- Clinical and anatomic visualization
- Desktop client development for visualization
- Web-based thin clients
- PACS integration
- ISO 13485, ISO 14971:2007
- IEC 60601-1
- FDA 21 CFR Part 820, Part 11
- Feasibility analysis
- Software risk analysis
- Compliance with certification standards
Verification & Validation
- Verification checklists
- Ground truth measurement validations
- Validation with software phantoms
- Validation protocols and tests
- Develop Design History File (DHF)
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)
Why Work With Us. Our Track Record.
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
Our disciplined design control documentation expedites the conformance process for obtaining FDA approval and 510K clearance for devices.