International

Due to its purchasing power, the US market is one of the most important global markets for medical products. All medical products that are to be sold in the USA must meet the strict requirements of the US Food and Drug Administration (FDA).

These seminar topics familiarize your employees with the necessary basic knowledge of FDA requirements and the prerequisites for access to the US market.

• FDA – Approval for medical devices

• Quality management requirements for medical devices in the USA

• Medical Device Single Audit Programm (MDSAP)

• UX and usability for medical software and apps