Xybel offers Consulting, Workshops, Seminars and Software, mainly focused on the Medical Device Industry.

We are a network of experienced specialists within all phases of the product development process:

Product/Design Strategy and Concept Generation (**Workshop Available**)

• Business Case Development (Business Model Canvas, 5 Forces, SWOT, etc)
• Pricing and Value Mapping
• Intended Purpose and User Needs
• Classification (Free SaaS tools available)

Detailed Development (**Workshop Available**)

• Requirement Specifications (House of Quality)
• Regulatory Issues
• Technical Documentation
• Instructions for Use (IFU)
• Risk Management
• Usability Engineering

Manufacturing (**Workshop Available**)

• Lean Principles (5S, JIT, Value Chain Optimization)
• Validation

Post Market Surveillance (PMS)

• PMS Plan and PMS Report (PMSR)
• Periodic Safety Update Report (PSUR)
• SaaS (beta)

Contact us today for a free assessment.