Device Master Record (DMR) checklist

duff999

Quite Involved in Discussions
#1
Hi Folks

I am interest to find out of a DMR high level overview or checklist is available to ensure I am capturing all the elements of what should be included. Any help would be appreciated

To date I have included the following:

  • Product and assembly drawings
  • COA's
  • Material specifications
  • Inspection and test specifications
  • Manufacturing instructions
  • Training materials
  • Drawings (tooling, fixtures, product, etc.)
  • Component procurement procedures
  • Workmanship standards
 
Elsmar Forum Sponsor
#2
All of the requirements come straight out of the quality system regulation:
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.
 
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