Good Manufacturing Practices, or GMP for short, are manufacturing practices that follow a specific flow of order to ensure that all products are consistent quality, meet the requirements, and have full traceability. We use a manufacturing flow process with critical sub-assemblies and in-process inspections to maximize the yield.
The patient is always first in mind when following GMP. We strive to manufacture products that are reliable and safe for clinicians, doctors, and patients. Device records are used for every assembly to assure consistency and GMP compliance. In our 11,000 square foot facility, we are more than ready to help you with your contract manufacturing needs. We can produce mechanical components and assemblies, electronic box builds, and electro-mechanical systems with motors, actuators, sensors, and electronics.
DesignPlex Biomedical’s commitment is to integrate quality into every aspect of our customer and business solution by our commitment to comply with the regulations and maintain the effectiveness of the ISO 13485:2016 certified Quality Management Systems.
CNC turning a custom framless motor housing for 3 phase DC motor.
Completed assembly of motor, ballscrew and bellows for hydraulic drive.
Completed Ventricular Assist Device pulsatile test fixture creating Wiggers flow and pressure using blood analog at 37C.
CO2 laser engraving and cutting up to 3/4" acrylic. (Also have 4-axis YAG laser marker for metals and plastics.)
Dip molding and oven curing of polyurethands and silicones.
Vacuum forming thin plastics.
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