Compass Biomedical
Compass Biomedical

Let Compass point the way

Consulting for Medical device Design and Development

Consulting for Medical device Design and DevelopmentConsulting for Medical device Design and DevelopmentConsulting for Medical device Design and Development
Learn More

Let Compass point the way

Consulting for Medical device Design and Development

Consulting for Medical device Design and DevelopmentConsulting for Medical device Design and DevelopmentConsulting for Medical device Design and Development
Learn More

Consulting Services

Design Control Systems

Design Definition & Documentation

Design Definition & Documentation

  • Procedure Development and Implementation
  • QSR and ISO Compliant
  • Flexible and Scalable

Design Definition & Documentation

Design Definition & Documentation

Design Definition & Documentation

  • Researching User Needs
  • Design Input Creation
  • Brainstorming and Collaboration
  • Establishing Unambiguous Requirements
  • Design History File and Traceability Matrix

Design Reviews

Design Definition & Documentation

Product Risk Assessment

  • Independent Reviewer
  • Design Review Chair
  • Preparing for Review

Product Risk Assessment

Product Portfolio Review

Product Risk Assessment

  • Risk Management System
  • Design, Process, and User Failure Modes Assessment
  • Benefit / Risk Analysis

Training Services

Product Portfolio Review

Product Portfolio Review

Training for                

  • Design Control Systems
  • Design Inputs and Definition
  • Risk Assessment

Product Portfolio Review

Product Portfolio Review

Product Portfolio Review

  • Identifying Market Segments
  • Assessment of Adjacent Markets
  • Evaluation of Market Gaps
  • Assessment of Devlopment Risk vs. Market Potential

Why Compass Biomedical?

Perspective

Over 35 years of engineering and project management experience, with over 30 years in medical device design and development.  "As a product development engineer, I understand the challenges of creating new product designs in a highly regulated environment.  I use my experience in design development to guide client organizations toward solutions that are compliant with regulations without limiting creativity." - Cathy Breiter, Founder, Compass Biomedical

Experience

  • Worked with medical device start-ups and multinational corporations 
  • Assessed design and business needs
  • Developed customized design control process procedures
  • Provided training on developing design inputs, risk assessment and navigating the design control process
  • Provided independent review for product design reviews
  • Researched user needs and design inputs
  • Managed multi-million dollar projects

Mission

At Compass Biomedical, the mission is to guide clients in building a strong foundation for their product development processes and product designs. We strive to exceed our clients' expectations and to build long-lasting relationships.

Contact Us

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801-599-6582

Compass Biomedical

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