Integrated medical device compliance that helps your business succeed
Services
QMS Implementation and Improvement
Let us help you develop, implement, and improve your medical device quality system.
Gap Assessments
Fractional Services
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.
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.
What People Are Saying
“Good insights on the best use of the [FMEA] tool.”
— 5th Annual Medical Device Human Factors & Usability Conference Attendee
“Very informative and well presented. Great Q&A after.”
— 5th Annual Medical Device Human Factors & Usability Conference Attendee
“In addition to hearing how to use a uFMEA, it was good to hear that other tools can fill the gaps.”