Start-up Support

• Development of Operations and Quality Assurance Strategy:
  • Organizational structure, Make / Buy Analysis, On-Shore vs Off-Shore Manufacturing, Degree of Vertical Integration, level of Automation
  • Growth Plan
  • Quality Assurance / Quality Control:
    • Regulatory Compliance Requirements, Risk Analysis, QMS and Complaint Handling Processes, Inspection and Test plan, Equipment Requirements
  • On-Shore vs Off-Shore Subcontracting 

• Regulatory Compliance and Submissions: GMP, ISO 9001 and 13485, CE Mark and UL/CSA compliance and certification,  510k Submissions

• Operations And Quality Assurance Start-up and Growth:
  • Facilities design and layout, Equipment Selection
  • Staffing Selection and Mentoring, Salary Ranges, Healthcare / Benefits, Job Descriptions
  • Implementation of LEAN Manufacturing Processes
  • Quality Management System Development
    • Customer-Centric Metrics
    • FDA & ISO (9001 & 13485) Compliant Documentation and Configuration / Design Control Systems
    • CAPA and Complaint Handling System Implementation
    • Quality Assurance tools: ProActive Quality, Poke-A-Yoke, PFMEA's & DFMEAS, 5 Why's, 6S
  • Supplier, Contract Manufacturer and Subcontractor Selection, Management and Support

• New Product Development, Validation and Launch
  • Market Requirements (Voice of the Customer), Product Requirements, Design Controls, Stage-Gate Release Process
  • Design for X input

• Customer Service / Field Service Process Development
  • Highly leveraged Call Center and Field Service Systems for optimized support at minimal cost

• Just about anything else that you might need help with .......when you work with a start-up you wear any hat that needs filling!