Webinar

Preparing a Device Master Record (DMR)


Design Transfer helps manufacturers to reduce business risks during the medical device design process. It ensures the company produces the right product with the right process and at the right price. The Device Master Record is the tool to ensure the right data has been provided for consistent and reliable production. 

In this webinar featuring Dr. Stephen Coulter, you’ll learn more about:

  • Device master record
    • Essential ingredients for your medical device DMR
    • Device master record template that you can use for team education
    • Different types of device master record example data & processes
    • The guidance documents that provide device master record definition
    • Types of device master record procedure SOPs your team can incorporate
    • Sample of what an FDA device master record example looks like

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    Presenters

    Dr. Stephen Coulter

    General Manager & Subject Matter Expert

    Dr. Stephen Coulter is the General Manager and Subject Matter for Nelson Labs company Regulatory Compliance Associates (RCA), bringing over 40 years of experience to his role. His areas of expertise include product development, design control, design transfer to manufacturing, technology partnerships, product lifecycle management, portfolio management and acquisition analysis. Steve’s regulatory affairs and quality assurance experience includes preparation of design history files or technical files for regulatory submissions. He has also participated in company advocacy efforts with federal agencies, congressional personnel, and public health groups.