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Quality Control

Quality is paramount at Jenitek. As a global medical device contract manufacturer, we maintain an ISO 13485-certified, FDA-registered, and NMPA-compliant quality management system designed to meet stringent medical industry requirements and international market standards. We integrate comprehensive quality assurance (QA) and quality control (QC) throughout every stage of our operations and production processes, adhering rigorously to global regulatory requirements and industry best practices. Through systematic testing, inspection, and validation, we ensure that every product meets the highest standards of safety, performance, and reliability-delivering consistently high-quality medical manufacturing solutions to clients worldwide.

Quality Systems Certifications

ISO 13485-2016 certified & FDA registered & NMPA-compliant
ASQ certified Six Sigma Black Belt team

Quality Engineering

We collaborate closely with customers to build quality into products at the design stage through the following methodologies:
 Advanced Planning Quality Planning (APQP)
 Failure Mode and Effects Analysis (FMEA)
 Statistical Process Control (SPC)
 Measurements System Analysis (MSA)
Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
We maintain comprehensive process documentation and full lifecycle traceability to comply with the latest medical device industry standards and best practices.

Quality Assurance

Our QMS ensures the highest standard of quality across products and services, tailored to meet your specific requirements by advanced metrology and measurement technologies. These capabilities not only verify compliance with all specifications and quality standards but also strengthens our ongoing continuous improvement initiatives.
Suzhou Jenitek is a fast-growing, professional contract manufacturer for medical devices that has internationally advanced level manufacturing capabilities.
   Tel: +86-512-66806001
  Email: Sales01@jenitek.com
   WhatsApp: +86-18136068160
Copyright © 2026 Suzhou Jenitek Medical Co., Ltd. All Rights Reserved. Sitemap Privacy Policy

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