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Quality Control

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Inventex provides invaluable expertise in navigating the convoluted regulatory requirements within today’s medical device and pharmaceutical equipment industries. We can help guide your approval to specific medical certifications and compliance testing, we ensure your products meet or exceed all relevant standards.

ISO 13485 certified quality control processes for manufacturing and assembly
ISO 9001:2015 registered facility
FDA registered
Compliant with 21 CFR Part 820
Six Sigma quality control processes
Class 8 Cleanroom assembly press
RF welding controlled environment
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ISO 13485: Crucial for
 Today’s Medical
Manufacturing Projects

ISO 13485 is the internationally recognized standard for quality management systems (QMS) in medical manufacturing applications. The standard was specifically designed around the meticulous requirements of medical device manufacturers and the strict industry regulations in place

The ISO 13485 standard establishes good practices for overall quality control, medical regulatory compliance, production process validation, as well as documentation and traceability. It also encourages a culture of continuous improvement, which Inventex Medical embraces through constantly refining our injection molding processes and integrating new state-of-the-art production technologies

Our Comprehensive Quality Control Process:

Design Validation – Inventex provides expertise in product development and design validation, both crucial for ensuring that medical devices meet end user needs, regulatory requirements, and intended performance standards.
In-Process Inspection – Once production is underway, Inventex continually checks, inspects, and ensures all specifications on parts and builds meet exact customer requirements.
Regulatory Compliance – Backed by decades of experience in the medical industry, Inventex possesses extensive knowledge of current regulatory compliance and certifications for injection molded medical devices. We help ensure your end products are optimized for patient safety, product quality, as well as market approval.
Complaint Handling – Inventex embraces effective complaint handling to address any quality issues or inefficiencies in the production process as they arise.
Product Life Cycle Management – Effective management of the product lifecycle allows us to optimize your products for all aspects of quality, compliance, and cost efficiency, extending from the initial product development stages to end-of-life.
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