At Haemonetics, regulatory compliance and quality assurance is more than a commitment; it is tangibly evidenced in every aspect of our operation.

With voluntary independent auditing and a dedicated Regulatory Affairs Department, Haemonetics focuses significant resources on regulatory compliance.

Haemonetics' Software Solutions Division was the first company to receive a Traditional
510(k) clearance for blood establishment computer 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."

Our Regulatory Affairs department consistently monitors industry regulatory observations and keeps abreast of potential regulatory issues. With memberships to the American Association of Blood Banks (AABB), the Regulatory Affairs Professionals Society (RAPS), the Certified Quality Auditor (CQA) program of the American Society for Quality (ASQ), and the IEEE Computer Society, our staff continues to keep informed about the latest regulatory improvements, theories, methods and tools.