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Glossary Term
Device History Record (DHR)
Definition
The Device History Record (DHR) is a compilation of records that document the production history of a specific batch or unit of a medical device. It includes information such as manufacturing dates, lot numbers, testing results, and quality assurance activities, ensuring traceability and compliance with regulatory requirements like FDA 21 CFR Part 820.
Relevance to the MedTech Industry
The DHR ensures that every medical device is manufactured in accordance with its specifications and regulatory standards. It provides a traceable record for quality control, troubleshooting, and post-market surveillance, supporting accountability and compliance.
Additional Information & Related Terms
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