We assist medical device manufacturers in preparing and maintaining Device History Records (DHRs) to document the manufacturing history of each device unit, lot, or batch. Our support ensures that the relevant production and quality records demonstrate that the medical device is manufactured in accordance with the applicable Device Master Record (DMR) and approved specifications.

Components of DHR includes

• Manufacturing date

• Quantity of device manufactured

• Quantity released for distribution

• Label identification

• Acceptance criteria for each testing

• Unique Device Identification (UDI) or Universal Product Code (UPC) or any other identification and control number

Our objective is to assist manufacturers in developing a traceable Device History Record that facilitates root cause analysis, manufacturing compliance, efficient quality investigations, and corrective and preventive actions (CAPA).