Full regulatory compliance audit and remediation program for a major hospital chain, ensuring all medical devices meet FDA requirements.
Location
United States
Duration
10 months
Project Value
$5M
Status
Completed
Comprehensive compliance audit and remediation for 20-hospital chain, achieving 100% FDA compliance certification
Auditing thousands of medical devices
Updating legacy documentation
Training staff on compliance procedures
Systematic device inventory and audit
Digital documentation system
Comprehensive training program
100% FDA compliance achieved
5,000+ devices audited and certified
Zero compliance violations
Staff training completion rate: 98%
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