With voluntary independent auditing and a dedicated Regulatory Affairs Department, IDM has focused significant resources on compliance issues from its beginning. IDM was the first company to receive a Traditional 510(k) clearance for blood bank software from the U.S. Food and Drug Administration (FDA) in 1995. IDM was also the first to receive a Special 510(k) clearance under the "New FDA Paradigm." A total of eleven submissions have been cleared with an outstanding record for product turn around time.

We are routinely inspected by the FDA as well as numerous customers. Previous audits included American Red Cross, Canadian Blood Services, ITxM/LifeSource, Roche Diagnostics, and Chiron. We have been found to be in compliance and have been rated favorably by the auditors.

IDM has an extensive Quality Management Program. The program's primary focus is meeting U.S. FDA Quality System regulations, but we've included aspects of Six Sigma, ISO 9000, and the CMM (Capability Maturity Model). The main objective of the program is to ensure safety in the design and use of the software we produce.