The FDA defines a Finished Medical Device as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Our Trelleborg Healthcare & Medical experts support customers in developing and assembling the medical device they require:
- Routine sub-assemblies involving silicone, metal, plastic and ceramic components
- Shunts formed from porcine-derived polymer
- Complete manufacture of fully functional neurological implants
- Device expertise is as varied as the requirements of our customers
Two examples of our medical device capabilities:
Implantable neurological sensing device
Silicone components including die-cut reinforced sheeting, a molded electrode positioner and tubing were assembled into an eight-electrode array.
The assembly process included fixtured positioning, bonding, laser welding, micro-crimping, laser stripping, and custom tray packaging. Pass-fail functional testing evaluated both electrical resistance and capacitance.
Novel mammary implant
The bill of materials involves 38 parts including dipped shells, precision molded valve components and extruded tubing. The process batch record fully details 58 discrete assembly steps beginning with line clearance and ending with product release as sterile finished goods. Serialized inner tray and shelf box labels are printed and controlled on-site. Each implant is laser etched with corresponding serial identification.