Integrated medical device compliance that helps your business succeed
QMS Implementation and Improvement
Let us help you develop, implement, and improve your medical device quality management system.
Gap Assessments
Our expertise in medical device regulations and standards can help you identify any gaps in your quality system or product documentation.
Experienced in European Union (EU) Medical Device Regulation (MDR) submissions as well as US FDA and other regional requirements.
Fractional Services
Our flexibility means that you don’t need to hire a full time (or even half time) Quality Assurance professional to handle your small business needs.
Nonconformance Remediation
Utilize our broad industry knowledge to bring systems and documentation into compliance with current regulatory body expectations.
Education
Let us create a customized course for your employees or help you create an education curriculum for your company.
Product Development
Let us help you define your product requirements so that they enable straight forward verification and validation.