Examples of medical device products in our portfolio:
Surgical equipment components
Ostomy bags for premature babies
Diagnostic drug test kits – molding, decorating and assembly
Vial vent filters – safety precaution for pharmacists
Cups and jars for organ harvesting
Luer caps and straps
Tubing connectors and clips
IQ – Installation qualification – We ensure that the equipment received matches the specifications we require and ordered, and that it is installed properly.
OQ – Operational qualification – We make sure the equipment runs the way it is supposed to run without material and prior to use in manufacturing.
PQ – Performance qualification – Finally, we test the machinery under load – in the case of a molding machine, this means with the amount of material it should hold, a mold in and running. We make sure that it effectively produces parts that fall within the intended capacity and function designed, and performs to medical qualification standards.
This three-step evaluation process applies to any type of machinery used in our medical manufacturing division.
Rely on ABISMOLD design expertise, medical qualification process experience and lean manufacturing when you need a seasoned source for plastic injection molded components and assemblies.