Professional Device Master Record Index Template. Device master record index for amylase. A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device.
The model of the dmr table should have a formal index form as. A lot of the documents are not in the device master record, but are referenced in the dmr as to where the document is located (document control office, engineering library,. Section 820.3(j) of the federal.
A device master record is a collection of every document needed to manufacture, package, and possibly service a medical device. Dmr is maintained on the company computer network in a microsoft word table, excel or equivalent format. This document is a device master record index for an in vitro diagnostic product.
| medical device validation, regulation,. Proprietary information in this index is replaced by x's. A lot of the documents are not in the device master record, but are referenced in the dmr as to where the document is located (document control office, engineering library,.
Section 820.3(j) of the federal. The device master record contains current device specifications and. In reading 820.181 and the fda guidance for device master record i cannot find any actual requirement for a controlled document called a dmr index.
The requirement for a device master record is outlined in the fda’s quality system. The device master record is a regulatory requirement for all medical device companies. Ensure compliance and streamline your process.
Device master record template $ 150.00 form/template used to organize and consolidate product information intended to provide the technical documentation details associated with a. Okay, here is a generic example of a dmr template for a medical device. The document defines four types of records that are important for medical device development and manufacturing:
