As a leading manufacturer of molded 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!
As an OEM ourselves, for decades, we developed winning proprietary methods and procedures. With a diverse product line, we had to develop the ability to set-up and change methods and materials, quickly and effectively.
We now offer these skills and methods as part of our contract manufacturing services.
We have extensive capabilities in preparing products to ship to distributors and/or OEM product producers. One of the advantages of working with us is as an OEM ourselves, we put the same care and workmanship into our assembly and packaging work for contract manufacturing customers, as we do for our own products.
With this 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.
