ISO 13485:2016 Certified Contract Manufacturer & FDA Registered

In an age of stricter regulations and intense focus on patient safety, medical device companies need to have complete confidence in their manufacturing partner’s ability to meet the highest levels of quality, control, and compliance. In medical device manufacturing, QUALITY MATTERS!

We have extensive experience serving leading producers and emerging innovators of medical devices and medical diagnostic product industry. Our business understands and adheres to the stringent requirements of 21 CFR 820, and is certified to ISO 13485:2016. Moreover, we comply with health and safety standards set by UL, IEC, and CE.

 Quality is evident in every phase of our manufacturing processes. From manufacturing transfer through delivery, we support you utilizing our ISO 13485:2016 certified systems for the contract manufacture of electromechanical medical devices, medical diagnostics, and disposables.

Inteprod has a consistent record of multiple audits with zero findings. These results are a reflection of our team’s experience, diligence, and dedication to quality and excellence.  At Inteprod, we know the medical products we produce for our clients save and enhance lives around the world; and, for us,

We Live our QMS!

 

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Our quality services include:

Process Control Documentation

Product & Process Verification

Nonconformance & Deviation Control

Corrective & Preventive Action

Compliance with Customer & Regulatory Requirements

Change Control

Strict Adhereance to the Device Master Record (DMR)

“We are committed to maintaining the effectiveness of our Quality Management System by supporting a high level of trained personnel who perform the controlled and monitored processes that we have in place. We work on products that save lives, and because of that….. We live our QMS!”