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Denise Wrestler

QA and RA Consultant, CYA Medical Device Consulting LLC

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.

Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ's monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.



  •  Wednesday, April 17, 2019
  • 12:00 PM PDT | 03:00 PM EDT,
  • 60 Minutes
  • $110.00
DMR, DHR and DHF - The Differences Between the Records and Files needed to Meet FDA Compliance

This webinar will define what each of these terms mean as defined within the FDA 21 CFR Part 820, including "human translations" to these often hard-to-read regulations.

  •  Friday, May 31, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • $110.00
The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs

A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations

  •  Wednesday, June 19, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $110.00
Effective Records Management & Document Control for Medical Devices

The document management system for medical device industry should help companies have control over critical activities such as:





  • Recorded
  • View Anytime
  • $150.00
Effective Records Management & Document Control for Medical Devices

The document management system for medical device industry should help companies have control over critical activities such as:

  • Recorded
  • View Anytime
  • 90 Minutes
  • $150.00
The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs

A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations

  • Recorded
  • View Anytime
  • 60 Minutes
  • $150.00
DMR, DHR and DHF - The Differences Between the Records and Files needed to Meet FDA Compliance

This webinar will define what each of these terms mean as defined within the FDA 21 CFR Part 820, including "human translations" to these often hard-to-read regulations.