As a leading manufacturer of molded and machined products for medical equipment, we are keenly aware of the importance of responsive custom assembly and packaging capabilities with a reliable supply chain. Resulting assemblies and packaging methods can make or break a product. We are FDA registered GMP compliant and with this and our ISO certification, we offer consistent high-quality work you can count on!
Our custom assembly and packaging capabilities include:
|FDA Registered GMP Compliant||Pressure Decay Leak Testing|
|ISO 13485:2016 Certified||Agile, Flexible Set-Up to Handle Custom Assembly – tubing sets|
|Low and Medium Volume Device Manufacturing||In-House Printing Capabilities of Custom Labels & Directions for Use|
|Custom Injection Molding of Components Available||UDI Barcoding for Class 1 & Class 2 Devices|
|Gamma Sterilization||In-Process and Final Inspections on Each Lot|
|Solvent Bonding||Reasonably Priced and On-Time|
|Ultrasonic Welding||Controlled Environment for Clean Sterile Manufacturing|
|Friction Fit Assembly||Biocompatible & Prop 65 Compliant Materials|
|Sterile and Non-Sterile Packaging|
As an ISO 13485:2016 Certified organization for medical device manufacturing, located in the United States in the Iowa heartland, we have demonstrated the ability to successfully deliver medical device plastics and related services that consistently meet our customers applicable regulatory requirements.
GMP is “Good Manufacturing Practice” and is a set of guidelines issued by the Food & Drug Administration (FDA) for a system that ensures products are consistently produced and controlled according to quality standards.