Our Mission
To work with clients to design, improve, and maintain user friendly integrated medical device quality system solutions that enable effective product development and sustainment.
Services
Gap Assessments
Fractional Services
Don’t need a full time quality assurance professional, but want someone on staff to handle the day to day quality assurance work? Let us provide you with reliable quality assurance resources when you need them.
Standards and regional regulations are constantly changing. We can help you identify any potential gaps in your quality system or product documentation and formulate a plan to close them.
Quality System Design and Process Improvement
Your quality system is an interconnected framework for product development. We can help you improve your quality system to achieve an easy to use process that enables efficient product development.
Specialties
Design Control
Establishing user and product requirements is the foundation for a good product design. Set yourself up for success by doing this right … the first time.
Human Factors
Designing a medical device that enables correct and effective use is an integral part of user and patient safety. Let us help you set up a plan to determine user interface requirements and demonstrate that they are met.
Risk Management
Risk management should be the center of the quality system. Learn how to use it as a tool to make risk based decisions, improve product quality, and reduce user and patient risk.