EG-GILERO
635 Davis Drive, Suite 100
Morrisville, NC 27560
T: (844) 344-5376
Website: www.eg-gilero.com

 

EG-GILERO is your single-source, trusted partner for design, development and contract manufacturing within the medical device, drug delivery, and primary pharmaceutical packaging markets. Acting as a seamless extension of your own internal resources, we accelerate speed to market of innovative devices from concept straight through commercialization.

EG-GILERO is truly different from other outsource partners. Design & Development is in our DNA. Our experienced engineering team provides a full suite of design and development services for your medical device and drug delivery device product development projects. Beginning with the end user in mind, EG-GILERO conducts clinical site user research, novel concept development, smart rapid prototyping, detailed engineering, and intellectual property (IP) management. By adhering to strict design controls and our ISO 13485 certified quality management system (QMS), EG-GILERO integrates human factors engineering (HE75) and design for manufacturability (DFM) throughout the entire development process.

EG-GILERO offers a complete range of analysis and Testing services performed by our own skilled engineers and technicians in our on-site mechanical and microbiological test labs. Utilizing established testing standards, or creation of custom test methods, EG-GILERO provides testing services ranging from engineering evaluations and formative studies to complete design verification and summative user validation testing.

EG-GILERO can develop the Regulatory strategy for your product and execute on all of the required elements, providing you a path to regulatory approval. We prepare and maintain regulatory design history files, conduct risk analyses including design and process FMEA’s, and develop packaging and labeling layouts for regulatory related needs. EG-GILERO routinely prepares and submits 510(k) applications to the FDA, as well as technical files for CE Marking and documentation to support new drug applications.

EG-GILERO’s in-house Tooling capabilities are unique and unparalleled in the industry. Our tooling capabilities range from single cavity, pre-production, fast development molds to high cavitation, valve-gated hot runner and two-shot systems.

EG-GILERO is your trusted Contract Manufacturing partner with a breadth of capabilities and a global reach. With multiple contract manufacturing sites in North America, Dominican Republic, and Asia, EG-GILERO has established expertise in cleanroom injection molding, cleanroom assembly, and sterile barrier packaging. From manual assembly with low cost labor, to high-volume, lights out contract manufacturing, we have a solution for all of your contract manufacturing needs.

EG-GILERO’s sole focus in medical devices and drug delivery devices throughout a product’s entire development and commercial lifecycle, positions EG-GILERO to uniquely provide the clinical and technical expertise you have been seeking in a true partner.