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Services
(Printable
Version)
GILERO is a mechanical design and development service
company located in North Carolina's Research Triangle.
GILERO serves the biomedical industry with a focus on
user needs, functionality, and manufacturability of
plastic and elastomeric medical devices. Our services
include:
Concept
Development
In a very short period of time, we will deliver photorealistic
renderings of multiple concepts, as well as high quality
prototypes to provide you with a hands-on evaluation.
GILERO assigns all intellectual property rights to its
customers so that you may, with peace of mind, continue
the development process using your own internal design
team or continue the engineering effort with us.
Product
Design
We begin our design effort with the end in mind by consulting
with users and manufacturing partners. These design reviews
and clinical product assessments speed the development
time and better assure the product is designed right the
first time. GILERO utilizes modern tools of product design,
including 3D computer-aided modeling, finite element analysis,
rapid prototyping, and techniques for rapid tooling to
provide our customers with high quality, quick-turnaround
results.
Process
Validation
Our training in quality allows us to easily integrate
the validation documentation into your existing quality
system, keeping your internal resources focused on production.
In the end, we deliver a complete and organized package
of protocols, reports, and supporting data for future
reference and the confidence to transition into full production.
GILERO can serve as a resource for a single component
of your development project, or manage the entire project from initial concepts
to mass production. Through our Device
Realization Process and compliance with FDA quality system regulations,
GILERO will deliver a design history file with documentation ready for 510(k)
submission. |
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