NAMSA

Geri Wagner is the CEO of NAMSA. To contact Geri Wagner email at [email protected] or [email protected].

The decision makers in NAMSA are An Liu, Dennis Nevins, Gina Skolmowski, etc. Click to Find NAMSA decision makers emails.

NAMSA provides a comprehensive range of services for medical device development, including clinical research, regulatory consulting, biocompatibility testing, materials characterization, and product development strategy. Their end-to-end solutions are designed to support medical device sponsors throughout the entire product lifecycle, ensuring compliance with global regulatory standards and facilitating successful market entry.

NAMSA's regulatory consulting services help medical device sponsors navigate complex regulatory environments, including FDA regulations and European MDR/IVDR requirements. Their team of experts offers guidance on submission strategies, documentation preparation, and compliance assessments to ensure that products meet all necessary regulatory criteria for approval and market access.

NAMSA primarily serves the medical device industry, but their expertise extends to various sectors within healthcare, including diagnostics, biotechnology, and pharmaceuticals. Their specialized services are tailored to meet the unique challenges and regulatory requirements of each industry, ensuring that clients receive the most relevant support for their specific needs.

Yes, NAMSA offers reimbursement consulting services to assist medical device sponsors in developing effective reimbursement strategies. This includes market access planning, health economics assessments, and payer engagement strategies to ensure that products are not only clinically effective but also financially viable in the healthcare market.

NAMSA conducts a variety of testing services essential for medical device development, including biocompatibility testing, sterility assurance, efficacy and functional testing, and lot release testing. These services are critical for ensuring that devices are safe, effective, and compliant with regulatory standards before they reach the market.

To get started with NAMSA's services, you can visit their website and fill out the contact form or reach out directly via phone or email. A member of their team will connect with you to discuss your specific needs, provide information on their services, and guide you through the process of engaging their expertise for your medical device development project.