Electronic device history records (eDHR) modernize medical device and diagnostics manufacturing. They replace paper with real-time error-proofing, guiding processes to minimize errors and enhance traceability, ultimately improving product quality for MD&D companies worldwide. What is an eDHR?

Feb 23, 2023 · Explaining what an eDHR (electronic device history record) is, what it includes, and why it's superior to a manual or paper-based DHR in the context of a QMS.

Jan 9, 2025 · An electronic device history record (eDHR) is a digital management tool that stores the information needed in a device history record. It provides the blueprint for ingredients and processes and the details of what happened during each manufacturing step.

MasterControl's eDHR software revolutionizes the DHR process, offering unmatched control over manufacturing data and documentation. Seamlessly connecting production and quality, our integrated eDHR software empowers medical device manufacturers with enhanced efficiencies and invaluable insights.

The Significance of Validation and Testing in eDHR Traceability: eDHR systems provide manufacturers with real-time visibility into their manufacturing process, allowing for streamlined record-keeping, improved productivity, and enhanced compliance.

Electronic Device History Record (eDHR) systems are designed to streamline DHR operations and provide several additional benefits related to electronic management of manufacturing execution.

Contact us today to discover how MasterControl’s electronic device history record (eDHR) system empowers manufacturers to create and deliver an easy-to-audit record of proper handling for every step in the production of a medical device.

See how QT9 helps medical device manufacturers with Device History Records (DHR) and Device Master Records (DMR). We do all of the validation for you. No extra charges. FDA 21 CFR Part 820 and ISO 13485:2016 Compliance: Easily document and trace manufacturing specifics for each lot, batch and unit.

Mar 7, 2022 · Learn why medical device manufacturers are digitizing their Device History Records (eDHR) to streamline compliance efforts.

Dec 2, 2021 · When it comes to verifying the quality of medical devices and diagnostics (MD&D), the eDHR (Electronic Device History Record) is a crucial tool. It enables manufacturers to gain complete visibility into their operation and make incredible strides in error-proofing and maintaining superior quality.