Design Outputs vs DMR (Design Master Record)

#1
I apologize if this is a stupid question, but I keep going back and forth about this and the posts I find about this topic (here and elsewhere) don't seem to agree.

Can anyone tell me (preferrably in layman's terms) excactly the difference between design outputs and the DMR?

a) Is the DMR a part of the design outputs?
Or
b) Are the design outputs a part of the DMR?
Or
c) Neither a) or b)


And if a) or b), what is the difference (the surplus) between the two?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
I apologize if this is a stupid question, but I keep going back and forth about this and the posts I find about this topic (here and elsewhere) don't seem to agree.

Can anyone tell me (preferrably in layman's terms) excactly the difference between design outputs and the DMR?

a) Is the DMR a part of the design outputs?
Or
b) Are the design outputs a part of the DMR?
Or
c) Neither a) or b)


And if a) or b), what is the difference (the surplus) between the two?
Hello - Welcome to the cove.
The DMR Requirements are:
PART 820 -- QUALITY SYSTEM REGULATION
Subpart M--Records
Sec. 820.181 Device master record.
Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
When incorporating this into ISO 13485 QMS I have combined the two.
Part of the design process is ensuring that all parts of the DMR are covered - so yes - the full contents of the DMR is a design output.


Other people may have taken a different path.
 

yodon

Staff member
Super Moderator
#3
Just to piggy-back on ScottK's excellent post, to answer your last question, not all design outputs are part of the DMR. The DMR is the 'recipe' on how to build the device. Some design outputs (e.g., software design documentation) are not needed in manufacturing.
 
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