A straightforward method for meeting FDA Requirements for Design Inputs and Outputs

Event Details

  • DateMon 18 November 2019
  • Time10:00 AM - 11:30 AM
  • VenueOnline
  • Location39658 Mission Boulevard, Fremont, CA 94539, USA Fremont National 9453
  • TypeWorkshop
  • Ticket$$ 110 per person
  • Table$Price for a table per table (seats Normally between 8-12)
  • ContactEvent Manager
    (510) 962-8903
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Overview A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both. The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process. Why should you Attend Better understanding of FDA regulations with regards to design input and output An organized approach in meeting design input and output requirements A simplified way to ensure design inputs and outputs are continually maintained and tracked Areas Covered in the Session Introduction to the DIOM template How to identify your design inputs How to categorize your design inputs and their sources Ways in which design inputs can be verified Common documents and activities used as design output evidence Additional requirements of design inputs and outputs Who Will Benefit Quality Assurance Regulatory Affairs Design Engineers Manufacturing Engineers Startup Companies Speaker Profile Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.