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NAMSA
MRO Program

proven development strategies to help you expedite market commercialization

How could you be saving valuable resources throughout the development continuum? Access our client testimonials to see NAMSA’s MRO Program in action.
Client Testimonials

23

Months of PMA Time Savings

$ 17 M

PMA Cost Savings

12

Months of 510(k)Time Savings

$ 7.5 M

510(k) Cost Savings

NAMSA’s Medical Research Organization (MRO®) Program is designed to accelerate great ideas into great medical products that advance healthcare today and into the future.

Medical device success is often measured in part by the critical components of cost-to-market and predictable development timelines. However, meeting these success measurements is frequently a challenge for device makers when utilizing the standard approach of engaging with multiple vendors to manage various development phases. Not only does this approach present uncoordinated starts and stops, it leaves device manufacturers susceptible to increased timelines and unplanned budgetary constraints.

 

Now, NAMSA has a solution to these common development challenges: our proprietary MRO Program service offering. This approach is designed to offer the full continuum of Contract Research Organization (CRO) services to take your medical device from concept to post-regulatory approval with savings of up to 23 months and $17 Million.

Starting with the end in mind, our team of global experts builds a strategy and execution plan for your intended claims, which includes the best-fit strategy for market access, reimbursement, clinical and regulatory objectives. This subsequently delivers phase overlap and vertical integration while also providing a single point of contact throughout the process

 

The industry now has a proven solution for more efficient utilization of development resources. When Sponsors partner with NAMSA, they realize proven outcomes of 30% savings in development timelines and cost minimization of 50%, on average.

Delivering Superior Results

“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factors in our success. Acting as a true extension of our team, NAMSA was relentless in delivering quality results in addition to proactively and expertly navigating any challenges that arose. Any medical device firm looking to achieve expedited, cost-efficient product development outcomes would be wise to select NAMSA as their trusted development partner.”

Etienne Binant, CEO, Biom’Up

An Unparalleled Breadth of Services
NAMSA offers end-to-end development services from consulting, regulatory, reimbursement, preclinical, toxicology, microbiology, chemistry, clinical and quality throughout every stage of the medical device development lifecycle. NAMSA’s in-house experts have extensive knowledge and experience in the most in-demand therapeutic areas and within all major markets of the world. 

Passionate Focus on Clients
We provide high-quality and insightful expertise focused on the best strategy for achieving your objectives. Our teams respond quickly to provide exceptional service and have the ability to manage any hurdle while mitigating concerns and delivering proven strategies and solutions. We go above and beyond the implementation of the work. 

Cross-Functional Teamwork
Our extensive team of experienced, dedicated, cross-functional Associates is committed to serving clients and look for ways to get products to market faster with regulatory rigor. We work with your team to develop and implement strategies that have demonstrated a reduction in time-to-market.

Delivering Accelerated Outcomes

“From preclinical testing, clinical trial management and regulatory strategy, NAMSA is truly expert at delivering high-quality outcomes throughout the entire medical device development continuum. Start to finish, NAMSA understood the required activities for accelerated development and efficacious market introduction. Undoubtedly, NAMSA played a critical role in Solvay’s successful product commercialization, all the while providing significant cost savings throughout our program. I would highly recommend NAMSA to any medical device Sponsor that is looking to achieve expedited, cost-efficient development outcomes.”

Shawn Shorrock, Global Director, Solvay Dental 360™

Case Studies

Case Study
Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent
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Case Study
NAMSA’s MRO® Approach Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings
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Case Study
NAMSA’s MRO® Approach Accelerates PMA Submission Timeline by 23 Months for Global Biosurgical Firm
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