Uncover new opportunities to optimize efficiency and improve performance using machine learning, deep learning, and natural language processing.
AI APPLICATION DEVELOPMENT
Create high value AI applications designed specifically for your workflows and your technical environments.
Manage complex regulatory issues and changing regulatory requirements to market your solution in the United States, European Union, and China.
1. Concept Definition & Planning
Our multidisciplinary consulting team brings top-tier business, machine learning, and medical informatics expertise to client projects. This accelerates customer progress in tapping the potential of AI ito improve clinical operations and product strategies. Our team gathers input from the client, reviews scientific literature, and available data assets to determine the differential value potential of alternative solutions.
- Opportunity Assessment
- Concept Definition
- Feasibility Study
- Regulatory Pathway Assessment
- Product Development Roadmap
2. Requirements Specification
We define requirements for data, document system interaction requirements, and conduct a hazard assessment.
- Systems Requirement Specification
- User Experience Assessment
- Hazard assessment
- Risk Mitigation Plan
- Validation Plan
3. Software Design
Our UX design team crafts human-centered digital experiences that seamlessly integrate into the clinical workflow.
- System Design Specification
- User interaction design
- System interaction design
- Algorithm design decisions
- Verification plan
4. Development & Testing
Our R&D team takes an agile approach to design and development. We bring over ten years developing applications for healthcare to every project.
- Machine learning code library and model
- Verification Test Results
- Validation Test Results
- User and System Documentation
- Defect Tracking
5. Clinical Validation
We include a clinical performance assessment in the development phase to allow for a fresh consideration of the regulatory strategy based on the landscape that exists at the time of the study.
- Research Protocol
- IRB submissions
- Regulatory submissions
- Marketing (labeling claims)
6. Deployment & Maintenance
We orchestrate customer IT support, clinical end-users, and administrators to effectively deploy solutions in your clinical environment.
- User and Operational Training Records
- Implementation Checklists
- Post-implementation surveillance records
- Complaint and defect tracking
Let's start something new together.