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  • Home
  • Capabilities
    • Prototyping
    • Design and Development
    • GMP Manufacturing
    • Cleanroom Manufacturing
  • Projects
    • Projects
  • News
    • Events
    • Press
  • About Us
    • About Us
    • Our Leadership
    • Quality
  • Contact Us

GMP Manufacturing

What is GMP Manufacturing?

What does that mean for you?

What does that mean for you?

Custom cable harness manufacturing and  testing using Cirris cable tester

Good Manufacturing Practices, or GMP for short, are manufacturing practices that follow a quality-controlled procedure 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. 

What does that mean for you?

What does that mean for you?

What does that mean for you?

Battery testing and analysis including capacity and internal resistance

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.

Quality Control

What does that mean for you?

Quality Control

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.  

Electronics Manufacturing

PCB Assembly

Electrical Leakage Testing

Electrical Leakage Testing


PCBs can be populated and box builds using IPC 610 and IPC 620 certified technicians and quality inspectors. 

Electrical Leakage Testing

Electrical Leakage Testing

Electrical Leakage Testing

Electrical Leakage testing can be performed in house as part of design screening prior to formal 60601-1-2, or can be used as part of in-process quality inspection.

Hi-pot Testing

Electrical Leakage Testing

Hi-Pot testing can be performed up to 5 kV in house as part of design screening prior to formal 60601-1-2, or can be used as part of in-process quality inspection.

PCB Debugging

Battery Testing

PCB testing using oscilloscope and logic anlayzer.


PCB debugging can be performed both in analog and digital (logic) circuits.  This is critical in the design phase as well as routine in-process inspection.

Battery Testing

Battery Testing

Battery Testing

Battery testing and analysis including capacity and internal resistance plus fuel gauge query.


Battery testing is performed in house to make sure all batteries used for FDA Class 3 devices meet their specifications.  In addition, battery design, battery thermal testing, and battery life testing can be performed at DesignPlex Bio.

PCB Testing

Battery Testing

Battery Testing

PCB testing using LCR meter at frequencies up to 1 Mhz

Using a precision LCR meter for PCB testing up to 1Mhz.  This is critical for very tight tolerance circuits with high frequencies routinely seen in VAD and TAH motor controllers.

Mechanical Manufacturing

CNC Machining


CNC turning a custom framless motor housing for 3 phase DC motor.

Motor Assembly

motor, bellows, ballscrew assemblies for pulsatile loop testing

Completed assembly of motor, ballscrew and bellows for hydraulic drive.

Laser Cutting and Marking

Laser Cutting and Marking


CO2 laser engraving and cutting up to 3/4" acrylic in addition to 4-axis YAG laser marking for metals and plastics.

Polymer Molding

Vacuum Forming Thin Rigid and Flexible Polymers

Laser Cutting and Marking


Dip molding and oven curing of polyurethanes and silicones.

Vacuum Forming Thin Rigid and Flexible Polymers

Vacuum Forming Thin Rigid and Flexible Polymers

Vacuum Forming Thin Rigid and Flexible Polymers


3-D printed molds are used to vacuum form parts with a variety of rigid plastics such as PETG and flexible plastics such as Polyurethane.

Finished Devices

Vacuum Forming Thin Rigid and Flexible Polymers

Vacuum Forming Thin Rigid and Flexible Polymers

Completed Ventricular Assist Device pulsatile test fixture creating Wiggers flow and pressure using blood analog at 37C.  

Medical Cable Manufacturing

Connector Assembly

Connector Assembly

TAH driveline connector with solder cups and potting

Finished panel mount cable assembly with epoxy potting.

Cable Assembly

Connector Assembly

Medical device cable assembly with stripper, pull tester, epoxy centrifuge, crimp and solder stations

Work Cell dedicated to cable manufacturing.

Backfilling

Epoxy back filling of medical device cables

Epoxy backfilling of connectors for strength and ingress protection.

Cable, Crimp and Solder Strength Testing

Pull testing as a part of design verification and for each batch of cables produced.

Cable Electrical Testing

Cable Electrical Testing

Medical device cable testing

Finished cable testing for resistance of each wire as well as resistance of every wire to each other, and every wire to the connector shell.

Crimping and Soldering

Cable Electrical Testing

Medical device power and signal port using crimp connectors

Crimping and Soldering to IPC Class 3 standards.

Ready to get your GMP medical product in people's hands?

Contact US
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DesignPlex Biomedical LLC

3425 Clayton Road East, Fort Worth, Texas 76116, United States

800 214 1009

Copyright © 2025 DesignPlex Biomedical LLC - All Rights Reserved.

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