NAMSA Services - Quality Assurance & Regulatory Compliance

As a trusted advisor, it’s critical that the appropriate measures are taken to ensure efficient and quality outcomes. NAMSA laboratories are accredited and certified by the required US government’s regulatory agencies. NAMSA's Four Phased Approach for safety evaluation of medical devices was designed to mirror the product development process. This methodology will help you move from an idea to a successful product as efficiently as possible with accurate and reliable test results.

Non-clinical safety studies, submitted to the U.S. Food and Drug Administration (FDA) as part of an application to market specified products, must be tested according to Good Laboratory Practice Regulations (21CFR, Part 58) "to assure the quality and integrity of the safety data." All NAMSA studies are performed according to basic "good manufacturing practices" including the use of written procedures, trained Associates, calibrated equipment, accredited animal facilities, proper data collection and storage, etc.

NAMSA has established many procedures to ensure significant control in testing programs. These procedures guide NAMSA through GLP protocols, quality assurance inspections and compliance. We are continually auditing NAMSA laboratory operations and introducing new controls and check points. We invite you to meet with members of our technical staff to discuss Good Laboratory Practice compliance and to inspect and evaluate our laboratories.

To ensure customer confidence, All NAMSA laboratories in the United States are accredited and certified by the governing regulatory agencies. To accommodate the unique regulatory and compliance needs of each individual customer we perform routine testing and audits.

For a complete list of accreditations and certifications, click here.