SHL complies with extensive regulations regarding safety, efficacy and overall quality of our products, which have 510(k) clearance according to the Federal Food, Drug and Cosmetic Act.

SHL is also subject to government regulations, most notably from the Food and Drug Administration (FDA) in the United States. Typically, it is our pharmaceutical partners who undertake the application of regulatory approval for their finished injection devices, however, we understand that this process is lengthy, expensive, and subject to unanticipated delays. Therefore, we offer our customers full support during the application process via a team of regulatory experts who are familiar with the stringent accreditation processes in various countries.