How could you be saving valuable resources throughout the development continuum? Access our client testimonials to see NAMSA’s MRO程序 in action.
客户感言23
数月的PMA时间储蓄
$ 17 M
PMA节约成本
12
510(k)月时间储蓄
$ 7.5 M
510 (k)节约成本
NAMSA’s Medical Research Organization (MRO®) Program is designed to accelerate great ideas into great medical products that advance healthcare today 和 into the future.
Medical device success is often measured in part by the critical components of cost-to-market 和 predictable development timelines. 然而, meeting these success measurements is frequently a challenge for device makers when utilizing the st和ard approach of engaging with multiple vendors to manage various development phases. Not only does this approach present uncoordinated starts 和 stops, it leaves device manufacturers susceptible to increased timelines 和 unplanned budgetary constraints.
现在, NAMSA has a solution to these common development challenges: our proprietary MRO程序 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-监管 approval with savings of up to 23个月，1700万美元.
以终为始, our team of global experts builds a strategy 和 execution plan for your intended claims, which includes the best-fit strategy for market access, 报销, 临床和监管目标. This subsequently delivers phase overlap 和 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. 当赞助商与NAMSA合作时, they realize proven outcomes of 30% savings in development timelines 和 cost minimization of 50%, 平均.
Etienne Binant, Biom 'Up公司首席执行官提供优越的结果
这是NAMSA专家测试的结果, clinical 和 consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted 和 extensive experience with the U.S. FDA让我们做到了无与伦比, 加速的结果, 但是他们的一致性, responsiveness 和 proactive nature were also key factors in our success. 成为我们团队真正的延伸, NAMSA was relentless in delivering quality results in addition to proactively 和 expertly navigating any challenges that arose. 任何医疗设备公司都希望实现快速, cost-efficient product development outcomes would be wise to select NAMSA as their trusted development partner.”
无与伦比的betvlctor伟德中文网站广度
NAMSA offers end-to-end development services from consulting, 监管, 报销, 临床前, 毒理学, 微生物学, 化学, clinical 和 quality throughout every stage of the medical device development lifecycle. NAMSA’s in-house experts have extensive knowledge 和 experience in the most in-dem和 therapeutic areas 和 within all major markets of the world.
热情关注客户
We provide high-quality 和 insightful expertise focused on the best strategy for achieving your objectives. Our teams respond quickly to provide exceptional service 和 have the ability to manage any hurdle while mitigating concerns 和 delivering proven strategies 和 solutions. We go above 和 beyond the implementation of the work.
跨职能团队
我们拥有一支经验丰富的团队, 专用的, cross-functional Associates is committed to serving clients 和 look for ways to get products to market faster with 监管 rigor. We work with your team to develop 和 implement strategies that have demonstrated a reduction in time-to-market.
Shawn Shorrock, Solvay Dental 360全球总监提供加速的结果
“从临床前测试, 临床试验管理和监管策略, NAMSA is truly expert at delivering high-quality outcomes throughout the entire medical device development continuum. 开始到结束, NAMSA understood the required activities for accelerated development 和 efficacious market introduction. 毫无疑问, 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, 有成本效益的发展成果.”