ABSTRACT
All records required by the Quality System Regulation and the Medical Device Directives must be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to auditors. There are four primary types of records that must be kept by every medical device manufacturer. These types are: Design History File (DHF), Device Master Record (DMR), Device History Record and Technical Documentation File. The design controls in CFR 21 820.30(j) require that each manufacturer establish and maintain a DHF for each type of device. The DHF contains documents such as the design plans and input requirements, preliminary input specs, validation data and preliminary versions of key DMR documents. The DHF contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of the Quality System regulation.
