Instru-med's Commitment to Quality

Our commitment to quality is built around our ISO 13485 Registration and our dedication to exclusively serving the medical device industry.

Our commitment to quality is built around our ISO 13485 certification and our dedication to exclusively serving the medical device industry. We received our initial registration of device establishment from the FDA in 1992, officially registered in 2012 and continue to comply with all regulations and requirements. Our quality practices and procedures are based on lean manufacturing principles and go beyond industry standards to provide our customers with unparalleled accuracy and unmatched precision. Our dedication to quality serves as the foundation of the company as we strive for excellence in every part we manufacture.

Quality Documentation

Will provide based on customer requirements.

  • Device History Records (DHR)
  • Certificate of Conformance
  • First Article Inspection
  • Control Plan
  • Gage R&R/Calibration
  • PFMEA
  • CMM Inspection

Quality Software Systems

ERP

Our enterprise resource planning system (ERP) offers the latest in manufacturing data management. It provides state-of-the-art order processing and tracking which allows us to quote, schedule, monitor, manufacture, ship and invoice with ease. It also allows us to provide our customers with immediate updates to ensure their projects stay on schedule. Our system has also been validated in accordance with industry standards to ensure accuracy.

QMS

Our quality management system (QMS) utilizes the latest in quality management software. Our system houses all of our critical quality documentation in one secure location which allows for maximum control and traceability; it has also been validated in accordance with industry standards.

Document Retention

Our document retention software provides unmatched traceability by allowing us to retain DHR files digitally. Our system allows all DHR files to be easily viewed and searched at any moment. All DHR’s are retained for 55+ years to ensure all necessary information is always available. All critical quality documents are contained on a secure server on-site and are backed up on servers located on the east and west coasts of the United States respectively. Our software has also been validated to ensure that all information is always accurate.

Validations

We strive for excellence in every part we manufacture.

Validated Machines and Special Processes