FDA Compliance
Successful approval for the US market

• Quality system according to 21CFR820
• Electronic records and signatures according to 21CFR part 11
• Risk analysis and risk reduction
• All steps completely traceable

The Food & Drug Administration (FDA) has defined strict rules for the approval of medical devices and their software and demands exact documentation of their observance.

apartis assists you in the production of your documentation for the required approval level, generally a minimum of 510(k)-approval.

We completely cover both the specification and the test areas. We begin by examining the status of your specifications and the validation process. With the help of reverse engineering we analyze your software, generate a complete trace matrix and determine the extent of the test.

Once the test design has been decided upon we conduct examinations at different levels, and document procedures and results according to the guidelines. Extensive risk analyses complete the spectrum.

If required we also assist you with the conceptual design and execution of clinical studies, especially in the areas of data acquisition, analysis and presentation of the results.