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
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.
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.
Gap Assessments
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.
Specialties
Small Companies
Cooperative Quality specializes in helping start up and small companies implement, improve, and maintain their quality management systems.
US and EU Markets
Cooperative Quality Solutions has over 15 years of experience working with the US FDA and European Union Notified Bodies and over 5 years experience helping clients obtain CE marking under the EU MDR. Let us help you update your QMS and create a technical documentation strategy to improve your chances of obtaining market clearance.