As a leading manufacturer of molded products for medical equipment, we understand the critical importance of responsive custom assembly and packaging capabilities. The 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!
With decades of experience as an OEM ourselves, we have developed winning proprietary methods and procedures. Our diverse product line has required us to quickly and effectively set up and change methods and materials.
We now offer these skills and methods as part of our contract manufacturing services.
We possess extensive capabilities in preparing products for shipments to distributors and/or OEM product producers. One of the advantages of partnering with us is out experience as an OEM ourselves. We apply the same level of care and workmanship to assembly and packing work for our contract manufacturing customers as we do for our own products. With our meticulous attention to detail, you can trust us to ship directly to your customers.
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.
All Molded Products, Inc., products are registered with the U.S. Food and Drug Administration (FDA) as Class I and Class II medical devices. Devices are classified according to the degree of difficulty or level of control necessary to provide reasonable assurance of its safety and effectiveness. Devices must be sold under conditions specified by regulatory controls.
