Product category: Consulting services for health organisations
MEDICAL DEVICE CONSULTING
With regulatory and reimbursement expertise in global markets, we bring clarity and direction to your process.
Delivering a medical product to market can be a long and complicated process, even when youre familiar with the regulatory requirements.
But when requirements are rapidly changing or when youre entering international markets, the process can seem insurmountable. Thats where medical device strategic consulting can assist.
REGULATORY CONSULTING At NAMSA, we provide efficient, responsive regulatory and quality services across the full spectrum of product design and development— and we stay with you for post-market support as well. From high-level expertise to practical working solutions, our staff develops and implements global regulatory strategies.
FDA CONSULTING We also prepare submissions, plan testing, manage communications with regulatory bodies, and provide ISO 9001 consulting. With our medical device consulting approach, you maintain project control while gaining the benefit of on-demand external support—whether its to extend your in-house capabilities or get access to the specialized expertise you need.
Product category: Certification and testing of medical devices, quality assurance, Technical equipment management, test houses / certification bodies
NAMSA CREATED THE MEDICAL DEVICE TESTING INDUSTRY.
We offer all testing services in our state-of-the-art laboratories located throughout North America, Asia and Europe. Our MRO® Approach ensures you have a coordinated team of experts attending to your needs throughout the testing process.
By working in coordination with our in-house Consultants, we look for ways to save you more time and reduce the overall amount of testing. Our technical specialists partner with you to develop a cost effective program, applying almost 50 years experience in medical device safety and regulatory compliance for your benefit.
NAMSAs balance of trusted advisers and proven process lets us support clients across the entire medical device product development spectrum.
NAMSA is leading contract research organization (CRO), and the worlds only medical research organization (MRO), providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.
We serve as your trusted partner, using our insight to identify strategies for saving time, while never compromising quality. We know that compromised quality can quickly take your product right back to the starting line. Thats why its so important to have a smart strategy from the outset—and why we put it at the forefront of every project.
The path to regulatory approval can be long and complex. We provide a reliable way to get there.