Consulting Services
Design Control Systems
Definition & Documentation
- Procedure Development and Implementation
- QSR and ISO Compliant
- Flexible and Scalable
Definition & Documentation
Definition & Documentation
- Researching User Needs
- Design Input Creation
- Brainstorming and Collaboration
- Establishing Clear Requirements
- Design History File and Traceability Matrix
Design Reviews
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
- 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
- Project Risk vs. Market Potential
Why breiter med device?
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, Breiter Med Device
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 Breiter Med Device, 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.