BUSINESS – Early-stage business services
Technical and product feasibility reviews
- Mechanical, electrical and manufacturability reviews
- Math & statistical model review
- IT and data model reviews
Formal planning documents
- Product Requirements
- Hazard analysis
- Design, Quality and Operations Plans
Quality Management Systems
- Protocol generation
- ISO 13485 review and management
Product reviews, safety screening and testing
- Creation of test protocols, data records and procedures
- Review/test to medical IEC 60601 and related
- Review/test to scientific IEC 61010 and related
- Electromagnetic compatibility screening
Product costing and revenue planning
- Operations cost review
- Pro forma income statements
Market research and planning
- Product-market reviews
- Competitive analysis
- Partnered with VitalNow for medical marketing
Operations
- Assembly and process review
- FMEA applications
- Cost accounting review
- Workflow, process and product cost review
