The customer wanted to produce and commercialize a biobsorbable implantable device for osteosynthesis and needed support in developing the technology and the necessary know how required to assure quality and performance of the device.
We support the customer in the design and process development for the injection molding of biopolymer implant.
We select the proper Implantable grade material able to assure the required mechanical and physical properties of the device.
We defined the specifics process parameter to monitor in order to control the process.
We performed IQ/OQ/PQ Validation of the Injection Molding production process.
We selected and define the physical, chemical and mechanical test needed to control the quality of process and product.
We supported the customer in selecting the proper sterilization method to assure the sterility and the necessary final strength of the material and device.
We supported in defining proper Regulatory path to register a class III medical device.
Controlled injection molding process. Device fullfilling the defined functional and design requirements.