Ensure your parts and components meet the stringent standards of the medical industry. Our facilities are ISO 13485:2003-certified for medical device manufacturing and FDA-registered as a medical device manufacturer. We also use an ISO 7 (Class 10,000) clean room with four all-electric custom plastic injection molding machines.
To verify the equipment used to produce your product complies with medical qualification protocol, we routinely perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) evaluations. This three-step evaluation applies to all machinery used in our medical manufacturing division.
Installation Qualification
We ensure the equipment received matches the specifications we require and ordered and that it is installed properly.
Operational Qualification
We make sure our equipment runs as expected without material and before it is used in manufacturing.
Performance Qualification
We test the machinery under load–in the case of a molding machine, this means with the amount of material it should hold, a mold in, and running. We make sure it effectively produces parts that fall within the intended capacity and function designed and performs to medical qualification standards.
We work alongside our customers to provide safe, quality products such as IV connectors and surgical instruments to the medical industry. We diligently follow FDA standards and adhere to ISO quality management standards in our Level 7 clean room. Our clean room is assembly-approved so we can assemble your manufactured medical devices and complex medical parts on site, ensuring end-to-end compliance for your most important parts.
