Quality Control
Quality control covers all aspects of the company’s operation, commencing with mold design, production processes and final inspection of completed products.  Our ISO 13485-accredited and FDA registered facilities provide the highest quality standards for your medical device.

Our strength in IQ/OQ/PQ and cGMP/QSR compliancy ensure your part will meet all of the requirements as planned from the beginning of the project.  From initial design all the way until final product assembly and packaging, we will build in stringent quality control systems that are put into place to verify each part maintains the highest level standards as needed.

Using our proven techniques and systemic methodology involving rigorous statistical qualifications and development of robust mold-specific processes we are able to ensure that parts will free of defects and of the highest quality consistently over the life of the project.  Coupled with the various negative feedback loops that are fully documented with traceability built into the production of your part, from the machine to packaging and shipping, we use employ a truly optimized manufacturing process.

Registrations include:
ISO 9001 Certified
ISO 13485 Certified
cGMP/QSR compliant
FDA Registered Facilities
CFDA Certified
CE Registered
CSA Compliant
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