Quality & Regulatory

An outstanding commitment to excellence is what makes Qure Medical a partner you can trust. Through a systematic process of continuous improvement and performance optimization, Qure maintains a steadfast focus on providing customers with products that exceed expectations.

Quality Process System

Qure operates the following:

  • ISO 13485 certified quality management program
  • Environmental management system meeting ISO 14001 requirements
  • Streamlined project management system providing full visibility and tracking of ongoing operations
  • Comprehensive molding process validations
  • Secondary and finishing operations within ISO Class 8 cleanrooms

 

Qure Medical is a member of ASQ, the global knowledge network that links the best ideas, tools, and quality experts.

 

 

Certifications

Twinsburg, OH

ISO 13485
ISO 14001
ISO 9001

Sturtevant, WI

ISO 13485

Rock Hill, SC

ISO 13485
ISO 14001

Nottingham, United Kingdom

ISO 13485
ISO 9001

Dongguan, China

ISO 13485

Quadra, North Canton, OH

ISO 9001

Automated Vision Inspection

Qure Medical prides itself on providing the highest quality components to its customers. To this end, Qure works with the customer to determine needs and expectations then works with its highly qualified vendors to develop custom automated inspection equipment that will meet or exceed expectations.

Work Management System

For quality parts delivered on time, Qure incorporates a custom Work Management System designed specifically for the company’s unique product launch and manufacturing processes.

This highly integrated system uses many avenues to improve communication throughout the production cycle, allowing key stakeholders to continuously monitor progress:

  • Facilitates interaction between managers and operators
    • Dashboards and process maps throughout each plant keeps entire facility informed
    • Real time text and email alerts require immediate action
    • Process audits provide consistency from shift to shift
  • Tracks key metrics, ensuring projects are on schedule
  • Allows easy creation of custom dashboards for specific projects
  • Inspection audits drive quality throughout the production process

Qualifications, Verification & Metrology

To ensure quality, precision parts, Qure strictly adheres to dimensional, technical and cosmetic requirements per customer specifications. Qure works directly with customer engineers to determine process validation requirements to ensure that products and processes are sound, viable and capable. Qure utilizes automated non-contact vision measurement equipment to perform dimensional analysis and statistical process control providing feedback to the operators and process engineers in a real-time setting.