Our customers expect the highest level of quality, and Foamtec Medical quality systems are designed to exceed those expectations.

From concept design to the production and shipment out the door, quality comes first. Foamtec Medical is vertically integrated in producing our own medical grade polyurethane foams, fabricating and packaging those products all within one campus. All products are manufactured under the Foamtec ISO 9001 and ISO 13485 quality systems, offering complete raw material traceability and measurable product consistency.

In the end, it’s our exceptional people who make the process work. The Foamtec Medical Product Development team will work closely with you, gain the understanding of your most critical requirements and design the highest quality product available utilizing our world-class equipment and processes.

Quality Manufacturing

  • Largest vertically integrated manufacturer of technical foam globally.
  • Only applicator manufacturer that produces technical and medical grade polyurethane foam.
  • US FDA registered facility for Medical Device Manufacturing.
  • ISO 9001, ISO 13485, and 21 CFR 820 (cGMP) compliant quality systems.
  • Validated sterile product by gamma irradiation, steam autoclave and EO sterilization methods.
  • State-of-the-art laboratory, foaming and fabrication equipment.
  • Proprietary, in-house designed machinery specific for device manufacturing.
  • Fully automated wash system utilizing high purity water for particle elimination.
  • Fabrication in controlled environments, including ISO Class 5 & 6 clean rooms.
  • Precision laminating, die cutting and application forming equipment using: Laser Technology & Ultrasonics