GMP Manufacturing

Good Manufacturing Practices, or GMP for short, are manufacturing practices that follow a quality-controlled procedure to ensure that all products are consistent in 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 produce whatever you need: mechanical components and assemblies, electronic box builds, and electro-mechanical systems with motors, actuators, sensors, and electronics.

DesignPlex Biomedical is committed to integrating 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.  

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

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 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.

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.

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.

Our in-house CNC turning a custom frameless motor housing for 3 phase DC motor.

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

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

Dip molding and oven curing of polyurethanes and silicones.

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.

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

Finished panel mount cable assembly with epoxy potting.

Work Cell dedicated to cable manufacturing.

Epoxy backfilling of connectors for strength and ingress protection.

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.

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

Crimping and Soldering to IPC Class 3 standards.