The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.

The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.

This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.

This audio conference covers:

• Role and development of the Device Master Record (DMR)
• The connection between the Design History File (DHF) and the DMR
• Function of the Quality System Record (QSR)
• Allocating information to the DMR or QSR
• The content of the Device History Record (DHR) including the requirements scattered across the regulation
• Explanations included in the preamble that help explain FDA’s intent
• Problems encountered by device firms and documented in Warning Letters

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who should attend?

• Quality Managers
• Quality Engineers
• Production Managers & Supervisors
• Production & Process Engineers
• Manufacturing Engineers
• Design Engineers
• Managers & Supervisors of Inspections or Testing