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Medical Device Division (Formerly Biomedical Division)

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Video Gallery

  • Presenter-Dianna Deeney<br />
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Technical Design Reviews are important meetings to hold with our team and management to make decisions about what we’re developing. We need the team to review the data, discuss it, and make an informed assessment based on data.<br />
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Slide decks are commonplace in technical design reviews. They are useful to the presenter to pull together a meeting, but terrible for the reviewers who need to review technical information and make decisions from it.<br />
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We review a case study from history, looking back at a tragic failure and the subsequent investigations that were held to determine how it could’ve happened. Consultants focused-in on the technical design reviews: how technical data was presented in a bulleted slide deck, and how that may have caused decisions that weren’t informed on the data.<br />
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There are alternatives to a bulleted slide deck. We review 3 alternatives with their scenarios and examples of their associated materials. We also discuss how to use them in your technical design reviews.<br />
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Speaker Bio<br />
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Dianna Deeney is the host of the Quality during Design Podcast and is the founder of Quality during Design. She coaches product development engineers about awareness and use of quality and reliability methods during the design development process. She is an engineer, a senior quality professional, and an active member of ASQ holding certificates as a CQE, CRE, CQA, and CMQ/OE. Dianna believes that design engineers do not need to become quality or reliability engineers to use those methods and benefit from quality thinking. She has seen that using quality as a strategic asset during concept and design development improves the design and the design process and helps design engineers to be recognized as star performers. Her mission is to bridge product managers and designers (entry-level to seasoned) to the world's quality initiatives and quality-minded people. Adding "Technical" back into Design R...
    Lisa Grosskopf
    0 Votes / 0 Comments
  • This presentation is an actual case study and will walk through a situation where Statistical Process Control (SPC) was used, after-the-fact, to assess a supplier’s problem with a critical heat-seal process. While SPC did not identify the root cause, an analysis of the historical data from this long-running process brought to light, to both the customer and the supplier, inappropriate acceptance criteria and unrecognized output variability. The study shows the value of SPC when applied to processes with output that can only be measured with destructive testing. Supplier Process "Line Down" - Invest...
    Lisa Grosskopf
    0 Votes / 0 Comments
  • Third of three webinar series.  This session documents actual case studies of conversion from Computer Software Validation to Computer Software Assurance (CSA) at Medtronic and Lantheus Medical Imaging.  It provides valuable information on actual implementation of CSA and the quality and economic benefits of the conversion. Conversion from CSV to CSA
    Lisa Grosskopf
    0 Votes / 0 Comments
  • The second of the three part series.  This session is an actual case study from Johnson and Johnson and provides valuable information on actual implementation of CSA. Computer Software Assurance case stu...
    Lisa Grosskopf
    0 Votes / 0 Comments
  • Part 1 of 3  Computer Software Validation is moving from a compliance-only activity to Computer Software Assurance, a value-added activity. Game Changer: Everything about FDA’s...
    Lisa Grosskopf
    1 Votes / 0 Comments
  • July 14, 2021 Dallas/Fort Worth Discussion Group webinar Simple, Quick, Practical Alternative to Performing Gage R&R and Specification Guardbanding presented by John Zorich Simple, Quick, Practical Alternativ...
    Lisa Grosskopf
    0 Votes / 0 Comments
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