Prototyping, design development, and manufacturing of medical devices

DesignPlex Biomedical LLC specializes in the prototyping, design development, and contract manufacturing of medical devices, focusing on Class 2 and 3 products. Their comprehensive services encompass a range of advanced technologies, including 3D printing, CNC machining, and laser cutting, which facilitate the creation of functional prototypes from initial concepts. The company employs a rigorous design methodology that adheres to ISO 13485 standards, ensuring a risk-based approach to mitigate potential product issues early in the development process. This includes the use of CAD models, schematics, and mechanical design techniques to enhance product reliability and robustness.

In addition to prototyping and design, DesignPlex offers extensive electronics manufacturing and assembly services in controlled environments that comply with Good Manufacturing Practices (GMP). Their capabilities include precision wire stripping, soldering, and the assembly of medical device cables, all performed under strict quality control measures. The company also emphasizes the importance of collaboration with clients and partners, leveraging their expertise in software and embedded firmware development to create connected medical devices. By integrating advanced technologies and a patient-centered approach, DesignPlex aims to deliver innovative solutions that improve treatment options and outcomes in the medical field.

United States

DesignPlex Biomedical is an ISO 13485:2016 registered company that designs, develops and manufactures Class 2 and Class 3 medical devices.  While our focus is primarily in cardiovascular and neuromodulation, we welcome any challenging medical device design or manufacturing that requires mechanical, electro-mechanical, electronics, or systems integration,  Our 11,000 sq. ft. design studio and dedicated manufacturing areas can accommodate small to medium production volumes.



DesignPlex Biomedical LLC

Company Details