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Quality & Regulatory

ISO 13485 Certified Contract Manufacturer, FDA Registered Facility

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!

At Inteprod, we have extensive experience serving leading producers and emerging innovators of medical devices and medical diagnostic products. We recognize the importance of quality and reliability in complex medical product manufacturing. We understand and adhere to the stringent requirements of 21 CFR 820; and, comply with the specific standards of ISO 13485 and health and safety organizations, including UL and Intertek.

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, Quality matters – a lot!

Inteprod's commitment to quality ensures the finished product will perform to your specifications. Contact Inteprod today to schedule a consultation with our team of experts.

Inteprod has a proven and robust Quality Management System, extensive medical device
and diagnostics experience, and we are absolutely committed to and capable of producing the highest quality medical products.

Our quality services include:

  • Process Control Documentation
  • Product & Process Verification
  • Nonconformance & Deviation Control
  • Corrective & Preventive Action
  • Compliance with Customer & Regulatory Requirements
  • Change Control

Recent News

Inteprod Achieves ISO 13485 Recertification.
Inteprod achieved ISO 13485 recertification, by accredited certification body, BSI Group which resulted in zero findings.

Click below to download any of our whitepapers
White PaperQuality Control & Assurance in Medical Device Manufacturing
White PaperTop 5 Things to Consider When Hiring a Contract Manufacturer
ISO 13485:2016 CERTIFIED - FDA REGISTERED 3007204745
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