Case Study: MicroMed Cardiovascular achieves accelerated compliance and increased efficiency with MasterControl

MasterControl Helps MicroMed Leverage Resources

MicroMed Cardiovascular, founded in 1996, is one of only three companies that produce a left ventricular assist device (LVAD) — a miniature heart pump used worldwide. The company’s paper-based quality system had become slow, error-prone and resource-intensive: weekly multi-hour document review meetings, ten staff dedicated to document handling, and insufficient controls to meet stringent FDA and CE regulatory requirements.

In 2011 MicroMed implemented MasterControl’s web-based quality management system to centralize document control, CAPA, training and change management across its U.S. and Netherlands operations. The system made the company audit-ready, sped CAPA and training processes, reduced headcount and IT costs through consolidation, and increased flexibility and productivity — allowing MicroMed to redeploy resources to product development and scale more effectively.

MicroMed Cardiovascular

Anthony W. Williams

VP for Operations