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.
EU Compliance Countdown:
EU Compliance Countdown:
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?
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?
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?
Device approval by the appropriate regulatory governing body is critical. Does your submission meet all requirements for clearance and is your team commercially ready?
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?
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.
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.
Navigating the EU’s Medical Device Regulation (MDR) ChangesJune 19, 2019
Exceptional Careers – Inspiring Experiences
Working at NAMSA will allow you to apply your expertise and knowledge to make a difference in the lives of others. Curious about our opportunities?