You’re moving from concept to launch. We know the best way to get there.
NAMSA is your trusted partner in medical device product development and clinical compliance support. We offer medical device manufacturers an optimal path to market with global expertise and industry-leading solutions. No matter where you are located, and no matter where you are in the process, we can address challenges across the entire product development spectrum. Even more, we can help you find that perfect balance between quality and cost that helps our clients come out ahead of the game. In today’s tight market, compromising quality for cost can quickly take your product from what you thought was the finish line right back to the starting line. That’s why it’s so important to have a smart strategy from the outset—and why we put it at the forefront of every project.
Our client engagements range from two-hour sessions, to onsite support, to monthly retainers. Our broad expertise spans key product development disciplines. Follow the links below to learn more about how we can meet your specific needs.
The following few examples of our medical device clinical consultation services begin to demonstrate the depth and breadth of our expertise.
- Protocol and statistical review
- Site and KOL identification
- Preparation for FDA
- Audit readiness for bioresearch monitoring (BIMO)
- Development of clinical evidence to support marketing claims and labeling
- Due diligence assignments for M&A activities
- Evaluation of clinical data quality and clinical data collection
- Regulatory Strategy
- Medical device marketing and strategy
Our regulatory consultants provide specialized expertise spanning many regulatory jurisdictions, including US FDA (mainly CDRH and CBER), EU/CE, Canada, Australia and beyond. Our consultants’ support ranges widely, including Notified Body selection, pre-IDE or early collaboration meetings, advisory panel meetings, pre-approval inspections, FDA District Office meetings, and more. We frequently consult in emergency situations involving warnings, regulatory actions, and product recalls.
Quality System Regulation (QSR) and ISO
Need an expert opinion about conformance to ISO 13485 or FDA’s quality system regulation? NAMSA’s consultants can recommend the most appropriate level of quality system for your company’s size, stage, and complexity. We can render an opinion about your existing quality system or recommend changes that fit your situation better. Whether you require design controls or supplier qualification or the establishment of a full quality system, our staff consultants are reasonable, flexible, and informed.
Biocompatibility, Sterilization, and Validation
A strong point of NAMSA’s depth and breadth of medical device-focused expertise is our consulting practice in the domains of biocompatibility, sterilization, and validation. We employ thought-leading experts in toxicology, materials science, sterilization, environmental monitoring and controls in production, general analytical chemistry, general microbiology, and process validation.
In today’s reimbursement climate, there are many obstacles on the optimal path to commercialization. We work to make regulatory approval simpler for you. We can advise you on a host of strategies that will help justify or position your medical device product for reimbursement or physician adoption. Our consultants come from backgrounds in medical device marketing and health economics, and they provide essential strategic thinking and counsel, before or after product regulatory clearance.