Quality Control

Inventex’s ISO 13485 Quality System helps medical device and pharmaceutical equipment companies navigating the convoluted regulatory requirements. 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 quality system for all manufacturing and assembly processes

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

ISO 13485 Quality System: 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 ISO 13485 Quality System:

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.

Quality Manufacturing Services You Can Count On

Inventex Medical delivers cost-effective production solutions backed by years of experience in plastic manufacturing and the medical industry. Our deep understanding of medical regulations gives us a competitive edge, enabling us to develop and manufacture innovative medical products with ease.

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