Global Center for Medical Innovation

Successfully Guiding Medtech Innovation

Our Mission

Our mission is to help direct the development, testing, and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients.

ISO13485 and 21CFR820 compliant processes

Manufacturer of record for clinical studies

Integral to the Georgia Tech innovation ecosystem

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Capital-efficient Phased Approach

Expertise in all relevant subject matter

Deep experience supporting innovators and startups

ISO13485-Compliant QMS

Services

We provide a full range of medical device development services

Prototyping

Market Assessment

Usability & Human Factors

Risk Analysis

Design History File Creation

Verification & Validation Testing

Professor Omer Inan
Omer Inan
Professor and Department Chair, Georgia Tech - ECE
"Don’t be afraid to engage the GCMI team early in the thought process and leverage their experience. They can really be helpful in putting the product development and commercialization structure around a broad range of medical technologies.”

Have an idea? Let's discuss it!

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saylan-headshot-dark

Saylan Lukas

Interim Executive Director

“I always enjoy getting the opportunity to go to surgery and see the products that I have worked on actually be used to positively impact patient’s lives.

Medical device product development is such rewarding work since we get to easily see a direct impact that the hard work produces.”

Medical Device Development Process

Phase 0

Feasibility

In this pre-QMS phase, all the messy details are worked out and de-risked. This is critical to ensure that not only can a device safely and legally be brought to market, but that the market and business strategy will support its adoption.
Phase 1

Concept

In the first Design Controls phase, plans for regulatory compliance, testing, manufacturing, and risk management are established. A Design History File begins here.​

Phase 2

Design & Development

In this phase, the design is frozen to allow the commencement of test article production required in later stages. All known risks must be addressed to avoid wasted time and capital in the later stages, which become increasingly costly.
Phase 3

Verification

In this stage, testing is performed on clinically-equivalent devices produced in an ISO13485 Quality Management System. Tests such as transit simulation, mechanical testing, and accelerated aging may be performed.
Phase 4

Validation

In this stage, the real test of the clinical value of the device is examined by assessing its effectiveness in the actual intended contexts of use.
Phase 5

Manufacturing Transfer

In this stage, the device has been de-risked and there is high assurance of its regulatory approval. Supply chain, logistics, and sales operations will be spooled up to coincide with regulatory and IP milestones to ensure a successful and profitable launch.

575 14th Street, Suite 100, Atlanta, Georgia, 30318

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info@devices.net

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