The implementation of new systems requires extensive planning and continual oversight. For this reason, the system implementation process is a collaborative effort between Haemonetics and the customer. It is the combined effort of both parties that ensures a successful implementation.

With voluntary independent auditing and a dedicated Regulatory Affairs Department, Haemonetics has focused significant resources on compliance issues from its beginning. Haemonetics' Software Solutions Division 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. We were 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.

Haemonetics Software Solutions Division provides consulting services for custom software development, validation and regulatory projects on either a fixed fee or time and expense basis.

Haemonetics is fully committed to protecting our customers' investments by anticipating industry demands and rapidly responding with the best technology available.