About Us

With over 20 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Holliday (formerly Wrestler) provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Holliday 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 Holliday holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine.  Ms. Holliday is currently working towards her M.S. in Regulatory Science from Johns Hopkins University. Additionally, Ms. Holliday holds several certifications including Regulatory Affairs Certification (RAC) - DEVICES through the Regulatory Affairs Professional Society (RAPS), ASQ certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA), as well as BSI ISO 13485:2016 Lead Auditor certification. A contributing author and technical reviewer to ASQ’s monthly publication Quality Progress magazine, Ms. Holliday remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Holliday 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. Ms. Holliday also serves as adjunct professor at the University of North Texas within the Biomedical Engineering Department.   

Schuler Medical Device, LLC provides services to individual clients as well as larger companies. 

“You can do what you want so long as it’s documented and justified and legal.” – Denise Holliday