Nextek Successfully Passes ISO 13485:2016 Audit, Strengthening Commitment to Medical Device Manufacturing Excellence

Madison, AL – July 28, 2025 – Nextek, A Company of Kontron, is pleased to announce the successful completion of its ISO 13485:2016 surveillance audit. This milestone underscores Nextek’s dedication to meeting the highest standards of quality and regulatory compliance in the manufacturing of medical devices and components.

 ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system specific to the medical device industry. Achieving this certification demonstrates Nextek’s ability to consistently meet customer and regulatory requirements throughout the product lifecycle, from production to testing and delivery.

 The audit was conducted by an independent, accredited certification body and encompassed a thorough evaluation of Nextek’s quality management system, including risk management, traceability, product realization, and process control.

 This achievement further positions Nextek as a trusted manufacturing partner for the medical sector, reinforcing its ability to deliver safe, effective, and compliant products. As part of Kontron AG, Nextek continues to expand its capabilities and global reach by providing mission-critical manufacturing solutions across the medical, aerospace, defense, and industrial markets.

 About Nextek, A Company of Kontron
Nextek is a U.S.-based provider of high-reliability electronics manufacturing services, proudly serving the defense, aerospace, medical, and industrial sectors. Headquarters in Huntsville, Alabama, Nextek is part of Kontron AG.

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Madison, AL 35758
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