635 Davis Drive,
Morrisville, NC 27560
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
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.
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