| A quality
technician checks the seal strength of breathable pouches |
| A vision system
(above) is used to align needle tips to an accuracy of
.008". Statistical process control charts (below) are
used to insure six-sigma quality. |
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| Our quality
systems are certified to ISO 9001/EN46001, ISO 13485, and are
FDA QSR compliant |
|
Resources
Our Quality Assurance staff includes engineers, technicians, and
inspectors who are highly trained in their respective disciplines.
Our staff can provide you with any answers to your quality concerns.
Quality System
Our entire quality system is maintained on our Lotus Notes
computer network, so the latest quality documents are available to
all personnel at the touch of a button. The system is used to track
and trend all aspects of the quality system, including internal
procedures, non-conforming material reports, corrective actions, and
customer complaints. The same quality system is used in both
facilities, insuring consistency in procedures and documentation.
Inspection and Test Capability
Our receiving inspection laboratory performs inspection of all
received raw materials, including visual inspection and performance
testing. We can perform attribute or variable testing using our
array of inspection equipment, including our Instron tensile tester,
Sprint leak testers, ARO Test-A-Pak system, and our SmartScope
high-speed visual inspection system. The lab also maintains our
calibration system for all inspection and test equipment.
Our manufacturing operators and quality inspectors perform
in-process inspections, testing, and audits to insure the quality of
your products. Designed experiments and SPC are routinely used
throughout the product development phase and carry over into the
routine manufacturing processes.
Sterilization Validation
We design, perform, and document our sterilization validations in
accordance with harmonized standards and accepted practice. We can
validate your products into our standard ethylene oxide or gamma
cycles, or design a cycle for your specific requirements.
Biological testing
With our own LAL test facility and partnerships with testing
laboratories, you can be sure that all sterilization and biological
requirements are verified prior to product release.
510(k) assistance
Need help with approval for domestic distribution? Let our
experience make your job easier. We can assist in filing your 510(k)
premarket approval paperwork.
CE Marking
With our ISO 9001:2000 and ISO 13485:2003 certified system, let us apply the CE
mark to your device for European distribution. |
