The Device Master Record (DMR)

The Device Master Record (DMR)

The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP.

Inputs and final product

The DMR constitutes the raw ingredients of the QSR. It is what goes into the QSR, while the DHR shows how these ingredients worked to deliver the final product. It needs to come with a Standard Operating Procedure (SOP), which defines the exact contents of the DMR, which will pave the way for the creation of an SOP for DHR, as well. One of the primary uses of a DMR is that being a master record; it tells employees the specific functions that need to be performed in the manufacture of a particular medical device.

No hard and fast rule about arrangement

Section 820.181 of the FDA spells out the requirements for DMR. A very important component of this section is that it does not make the type of arrangement of information about the device watertight. It gives sufficient freedom to manufacturers of medical device in that they are free to write information about it in any manner they like, so long as it is easily accessible.

Device specification –the core of the DMR

The foundation or what may be called the preface to the contents of the DMR is device specification. This section of the DMR briefly lists out all important details of the external nature of the device. Usually, a DMR device specification has the following:

  • the device’s product trade and common name(s)
  • intended use(s)
  • environmental limitations and product stability
  • important components and formula (if applicable)
  • performance characteristics and theory of operation
  • physical characteristics
  • regulatory classification
  • user safety characteristics.

References:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122576.htm

http://www.globalcompliancepanel.com/control/w_product/~product_id=600076LIVE

 

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Is a completeDevice History Record a must?

Is a completeDevice History Record a must?

This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with.

Please, please, do not take the DHR for granted. Of course, if inviting a recall is on top of your mind, go ahead and skip any of these steps:

1. The exact date of manufacture of your device, batch, or lot;

2. The precise numbers of the devices you manufactured;

3. Out of these, the actual number that was accepted and taken up for distribution;

4. Most important: All records that show that your support devices are being manufactured as specified in the DMR;

5. Another very important one: Make sure you have included a copy of the ACTUAL product label consisting of carton and/or pouch, along with the product’s Directions for Use;

6. Whatever extracontrol numbers, identification, or serial thatyou may have included.

So, why miss out on any critical information? Just make sure that all these are retained in your DHR. Never ever forget this: You are safe when you document. It is not only your best protection against errors in the process which you can identify at that exact stage and set right at the exact place; it also makes sure FDA cannot catch you by the scruff of your neck. What greater defense to show the FDA than your actual documented records? The FDA is there to check your compliance with QSR, and let us make it easy for them.

http://www.medicaldevicesummit.com/Main/Blogs/57.aspx

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801