The FDA QSR and the Medical Device Directive specify certain records that should be included in your organization's quality system - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical File (TF). Price: $245.00USAGlobalCompliancePanel,Livermore Common, Fremont, CA, 94539USA Phone:800-447-9407Fax: 302-288-6884