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.