A Bakery and a Medical Device Quality System

An overview of FDA’s Quality System Regulation commonly known as a Quality Management System.

A baker knows their product. The ingredients, the process to produce the product, what is good or not acceptable, and the customer is the last inspector.

So, why have a Quality Management System?

  • What is its value?
  • What is its structure?
  • How does it help retain customers?

This 1-hour session will provide you with an overview of FDA’s Quality System Regulation (QSR) commonly known as a Quality Management System (QMS).

Your takeaway should be the ability to talk in generalities regarding the QMS and
why it is one of a companies core business processes.

Event Speakers

James Rusty Lusk

James (Rusty) Lusk

Quality Systems International

James (Rusty) Lusk has 40+ years of experience in FDA/ISO regulated industries from early-stage to Fortune 100 companies. He is currently with Quality Systems International, a consulting company serving FDA/ISO regulated industries with a focus on Medical Devices. He is the co-inventor and co-developer of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life. He co-founded LifePulse, LLC to develop and market the product. He is an active member and on multiple occasions the past President of Orange County Regulatory Affairs (OCRA), a nonprofit organization educating the regulatory professional.

Event Partners


The SBDC @ UCI Applied Innovation is a resource for any high-technology, high-growth, scalable venture from both the Orange County and UCI ecosystem that needs assistance with business planning, business development and funding-readiness. The center hosts several VC and Angel investors on site, as well as various ecosystem partners and industry professionals who work closely with the entrepreneurs.

Meet with the Small Business Development Center (SBDC).

Whether you’re looking for guidance with starting your new tech venture, obtaining angel or venture capital, or looking for SBIR/STTR assistance, we're here for you!

Register Now

Event Details

Thursday, October 14, 2021

12:00pm - 1:00pm

Join us for a virtual Lunch & Learn.

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6:00PM - 8:00PM

MedTech Minds

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Apply for residency today

Do you have a great company in the bioscience or medtech industry? Do you need wet-lab and/or fabrication space to develop and test your product?


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