Case Study: Hologic achieves FDA UDI compliance with Oracle Exadata

Regulatory Compliance: Hologic First To Meet New Affordable Care Act Requirement

Hologic, a Bedford, MA medical device company, faced new Affordable Care Act and FDA Unique Device Identifier (UDI) compliance requirements while also supporting its mission to improve patient outcomes. To address these challenges, Hologic relied on Oracle Exadata as part of its Oracle-based IT foundation, including Oracle Agile PLM, Oracle E-Business Suite, Oracle Business Intelligence, and Oracle Hyperion.

Oracle Exadata helped Hologic run enterprise applications faster and more reliably, while Oracle Agile supported product collaboration and regulatory documentation. Working with Oracle and partner Inspirage, Hologic built a solution to gather and transmit device data to the FDA’s Global Unique Device Identification Database, and became the first medical device company to transmit its UDI data to the FDA.

Hologic

Dave Rudzinsky

Senior Vice President of Information Services and Chief Information Officer