Does your medical device or IVD product run the risk of noncompliance? Take the steps today to ensure your device remains readily available throughout the EU marketplace.

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NAMSA is the only Medical Research Organization…

…that reduces time to market & costs for medical device product development.

We do this by providing global expertise in Consulting, Laboratory Testing Services & Clinical Research.

It’s called the MRO® Approach.

Concept / Feasibility

 

Your innovation starts here – Charting your strategy from bench to bedside is underway. Do you know how to minimize product development risk at this stage?

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Design Validation & Preclinical

 

Your innovation becomes a product that needs to be evaluated, refined, and finalized. Have you created a testing strategy to save you time and money?

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Clinical

 

The successful evaluation of your product through human clinical trials in a timely manner requires experience. Do you know how to streamline this stage in your development?

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Market Approval

 

Device approval by the appropriate regulatory governing body is critical. Does your submission meet all requirements for clearance and is your team commercially ready?

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Post-Market

 

Post-market surveillance to monitor the safety of your device is imperative. Does your post-market strategy include physician training, lot release testing, or quality audits?

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NAMSA’s medical device experts work across a multitude of therapeutic areas including Cardiovascular, Orthopaedic, IVD, and Wound Care. The combined experiences of our specialists, enables us to customize your quality system, design validation, testing, and clinical trials to your specific therapeutic needs.

NAMSA MRO® Approach

NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.

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Contact Us

+1-866-666-9455 (toll free) +1-419-666-9455 (outside of USA) +1-419-662-4386 (fax)

Email & Social Media

clientcare@namsa.com | LinkedIn | Twitter

Therapeutic Expertise

Therapies that affect physical or biological processes of the body are known as “medical” therapies. These therapies can include medications, alterations in diets, changes in sleep habits, increased physical activity, stress reduction and more. NAMSA has extensive medical device testing and clinical trial experience across all of the therapies listed below. Click to find out more or contact us directly.