Publishes guidance for biological evaluation of medical devices.

NAMSA tests biomaterials and medical devices for biological effects. Its services include chemical analysis, cytotoxicity, irritation, sensitization and other studies selected for the material and its use. It lists testing labs in the United States and Europe. A service listing does not prove that a material or finished device is safe or approved.

Nelson Labs provides laboratory tests and advice for medical devices and related products. Its Salt Lake City headquarters lists biocompatibility, toxicology, extractables and leachables, material performance and sterility testing. It is part of Sotera Health. The required test and the chosen lab need a separate check; a group service list does not establish each lab’s approved scope.

Eurofins Medical Device Services tests device materials and finished devices through a network in North America, Europe and Asia Pacific. It lists biological testing, chemical analysis, extractables and leachables, and reviews of changes to materials or manufacturing. This entry describes Eurofins services, not blanket approval of a device or every laboratory’s scope.

Output: Material & Biological Testing Outputs.

Output: Regulatory Review Outputs.

Test results for device developers and reviewers.

Guidance and regulatory review for product developers.

Read the source for scope and details.

Read the source for scope and details.

Read the source for scope and details.

Read the source for scope and details.

Read the source for scope and details.

Explains risk-based biological evaluation of device materials; material data alone do not approve a device.