"We have the expertise to get it right the first time."
~ Stephanie Harrington, Founder

Matrix Medical Devices provides the regulatory and quality expertise to navigate US FDA and International Regulatory approvals, so you can focus on developing the technology.

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Our senior-level team is experienced in all facets of the commercialization process giving you reliable, comprehensive and efficient program management every time.

We provide FDA and ISO Quality System infrastructure and expertise. Our Device Matrix supports and ensures submission and compliance requirements for domestic and international medical device industry markets.

From project management and regulatory submission, to post-market surveillance and remediation, Matrix Medical Devices is your regulatory and quality partner.

Our Services

Accelerate your product commercialization.
Matrix Medical Devices offers a robust regulatory and quality foundation, enabling an efficient development process for current and future products.
 
In addition, we offer other resources for growth including due diligence, organizational assessment, design transfer guidance and a quality supplier network.
 

FDA/Regulatory

Our team will outline a complete 510(k) or PMA regulatory strategy based on your business goal. Our team offers scalable support, including regulatory strategy, gap analysis, and procedures.

Quality Systems

We’ll establish a sound quality foundation from the onset and help you maneuver through the process with assurance.

Program Management

With “hands-on” technical experience in product development and production, we also provide expertise on product development priorities and critical-path activities.

Clinical Studies

From preparing FDA IDEs to clinical study kick-off, we provide the expertise and input to achieve the clinical study outcomes that will establish your product’s value proposition.

About Us

With over 125 years combined experience in medical device commercialization -- providing success and stability for our clients is our #1 priority.
 

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