Understanding and Implementing the DMR, DHR and QSR - Webinar CD/Transcript

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Understanding and Implementing the DMR, DHR and QSR

The FDA expects manufacturers to maintain documents that describe the design and production of the device - Design History File (DHF), the Device Master Record (DMR), the Device History Record (DHR) and the Quality System Record (QSR).

But knowing what exactly the FDA is looking for in these documents and how they relate to each other can be very confusing.

Industry expert Dan O’Leary of Ombu Enterprises, LLC, will explain and clarify the differences between each record, how they relate to each other, and demonstrate how to implement the requirements.  Understanding these elements will ensure a smoothly functioning QMS and FDA compliance.

In ninety minutes, you will learn:

  • The required elements in the Device Master Record (DMR)
  • The source of the Device Master Record
  • The required elements in the Device History Record (DHR)
  • The linkage between the DMR and the DHR
  • The requirements to release a device for distribution
  • The relationship between the Device History File (DHF), DMR, and DHR
  • The role of the Quality System Record (QSR) and ensuring you have one
  • The effect of UDI on these required records
  • The changes in ISO 13485:2016 related to these records
  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Design & Development Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing engineers
  • Individuals designated to release product for distribution
  • Individuals designated to inspect, manage, and use labels

Dan O’Leary, President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. 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.