DesignPlex Biomedical LLC

DesignPlex Biomedical LLC is a medical device company based in Fort Worth, Texas, founded in 2015. The company specializes in the prototyping, design development, and contract manufacturing of FDA Class II and III medical devices, focusing on cardiovascular and neuromodulation technologies. DesignPlex is ISO 13485:2016 certified, ensuring compliance with high-quality and regulatory standards. The company addresses gaps in early-stage medical device development, particularly for implanted blood pumps and artificial hearts. Their services include creating functional prototypes, employing a risk-based design approach, and following Good Manufacturing Practices for consistent quality. DesignPlex operates ISO-7 certified cleanrooms for sterile assembly and offers comprehensive contract manufacturing services. They have worked on numerous projects, including ventricular assist devices and innovative treatments for chronic pain through optogenetics. DesignPlex aims to be a premier partner for medical device innovators, supporting them from initial concept through to commercialization.

• Employees17
• Founded2015