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Glossary Term
Device Master Record (DMR)
Definition
The Device Master Record (DMR) is a compilation of all the instructions, specifications, and records necessary for manufacturing a medical device. It includes design outputs, material specifications, quality assurance procedures, and packaging instructions, ensuring that the device can be consistently produced in compliance with regulatory and quality standards.
Relevance to the MedTech Industry
The DMR serves as a blueprint for manufacturing medical devices, ensuring consistency, quality, and compliance with regulations. It provides manufacturers with all the necessary details to produce a device that meets its intended use and performance specifications.
Additional Information & Related Terms
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