Sign up  

Law Office of Yvette R. Lloyd

Contact:  Yvette Lloyd, Consultant
Specialty: Devices, IVD

Yvette Lloyd provides legal and regulatory compliance consulting to the medical device and in vitro diagnostic device industries. 

Areas of expertise include:

  • Quality Systems remediation (US/international regulations)
  • Compilation and submission of US regulatory filings (e.g., 510(k)s)
  • International regulatory affairs, including development and review of technical files/dossiers for submission to Competent Authorities
  • US and International Post-Market Surveillance (including Adverse Event Reporting and Recall activities)
  • Labeling review (Including advertisements and promotional materials)
  • Due diligence for merger and acquisition activities
  • Contract review
  • Quality and Regulatory auditing, including FDA QSR, ISO 13485
  • Pre/post market risk management reviews
  • Design review, including development or remediation of design history files
  • Quality Management system implementation and maintenance
  • Quality system and regulatory compliance training

Yvette Lloyd has over 25 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical and in vitro diagnostic medical devices. Yvette started her career as a research chemist for an in-vitro diagnostic company. That initial career lead her to a career path in regulatory affairs and compliance, where she ultimately became the Regulatory Affairs Manager for a cardiac and respiratory medical device company. Yvette attended law school while working full-time, and later transitioned to the role of an attorney in 2005. Since 2008, she has been providing consulting services to regulated healthcare companies. She has also served as an instructor for the University of California-Irvine Extension Program, as well as for Argosy University College of Undergraduate Studies. Yvette holds degrees in Biological Sciences and a Juris Doctor, and is a licensed attorney in the state of California. Yvette is fluent in Spanish.

Years in business: 12 

   (714) 307-3469
alt   This email address is being protected from spambots. You need JavaScript enabled to view it.