InterX Technologies, headquartered in Plano, Texas, is a medical device manufacturer specializing in non-invasive neurostimulation devices for pain management and rehabilitation. Their innovative technology is designed to deliver safe, effective, and drug-free solutions that improve quality of life for patients worldwide. InterX is committed to maintaining the highest standards of quality and compliance, holding ISO 13485 certification and aligning operations with global regulatory requirements.
The Situation
The journey and partnership with InterX Technologies began in 2017 with an initial ISO 13485 internal assessment. As a small-sized medical device company, InterX faced challenges in maintaining compliance while keeping their QMS practical and tailored to their size. With upcoming re-certification, InterX needed to ensure readiness for both their certification body and FDA inspections.
The Solution
TMAC partnered with InterX to strengthen and improve the Quality Management System over several years, focusing on scalability and regulatory alignment. In 2025, TMAC performed a comprehensive ISO 13485 assessment, ensuring that InterX was prepared for the upcoming re-certification audit and FDA inspection. This engagement was supported by MedMMAP funding, which covered 75% of the cost for the manufacturer.
The Results
Successful FDA inspection with zero observations
Successful ISO 13485 re-certification with zero findings
Estimated cost avoidance of $25,000 by preventing remediation costs typically incurred after findings (internal rework, consultant support, certification body follow-ups, and shipment delays)
Additional $4,273 in direct savings through MedMMAP funding support, which offset 75% of the project cost.
“The assessment prepared us so well and did not come at a better time. We had a re-certification audit and FDA inspection back-to-back. We are so grateful that we had such a thorough assessment and were prepared.”
– Jenny Tejeda – Quality Management Representative
