Capabilities - Business

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


  • Assembly and process review
  • FMEA applications
  • Cost accounting review
  • Workflow, process and product cost review