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.
Upcoming Webinar
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Recorded Webinar
The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with FDA design development regulations and are looking for a place to start in their path towards compliance.
Recorded Session Get life time access for one participant with download option!

Effective Records Management & Document Control for Medical Devices
Even the smallest of changes often requires an excessive amount of time to prepare submit, distribute, and implement change requests, document modifications, document review meetings, document approvals, and document placement. This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
Recorded Session Get life time access for one participant with download option!

FDA Part 820 Basics - Everything you Need to Know to Get your Start-up Company Compliant
This presentation will provide you with a basic understanding of the regulations listed within 21 CFR Part 820, teach you how to apply regulations into your company documentation, describe the must-have systems required for your QMS, help you develop a checklist plan for ensuring all elements of the regulations are incorporated into your QMS, and better understand the scope of what will be needed to meet FDA requirements.
Recorded Session Get life time access for one participant with download option!

Effective Records Management & Document Control for Medical Devices
Even the smallest of changes often requires an excessive amount of time to prepare submit, distribute, and implement change requests, document modifications, document review meetings, document approvals, and document placement. This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
Recorded Session Get life time access for one participant with download option!

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