EduQuest: A Global Team of FDA Compliance Experts   presents a proven, 2-day training class on FDA's expectations for your Quality System -- and the consequences of non-compliance

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QSR Compliance Basics:

Complying with FDA's 21 CFR 820 Medical Device Quality System Regulation (QSR)


Available as an On-Site, On-Demand class

 Email to bring this class directly to your site -- when and where convenient for you

Get interactive, real-world classroom training on the essential FDA Quality System rules you must know. 


The scope of FDA’s Quality System Regulation (QSR) is huge – more than 500 pages of rules and guidance – and non-compliance is not an option. Just within the past 18 months, more than two dozen medical device companies have received Warning Letters for deficient quality management programs, and several were threatened with removal of their products from the market.


Compliance with FDA’s Quality System approach is recognized globally as a pre-requisite not only for getting your product on the market but – just as importantly – keeping it there. This two-day QSR Basics course walks you through the requirements of 21 CFR 820, discusses how FDA’s rules correlate with ISO standards and ICH guidance, and examines current FDA inspection and enforcement priorities.

Learn directly from former FDA device officials and industry advisors.

Learn straight from the source – former FDA inspectors, rule-makers, and trainers from the global consulting team of EduQuest, headquartered near Washington, DC. Instructors include one of the co-authors and trainers of FDA’s Quality System Inspection Technique (QSIT) and the founding editor and co-author of FDA’s “bible” for inspectors, the Investigations Operations Manual (IOM).

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Why you should attend:



Course Curriculum

QSR Compliance Basics:

Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation


Class Schedule:

Day 1: 8:30 a.m. – 5:00 p.m.; Day 2: 8:30 a.m. – 5:00 p.m. U.S. Eastern Time


Why trust your training investment with EduQuest?


EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating more than 20 years of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.


Since that time -- through hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.


"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems)


About your Course Instructor:

Internationally recognized Device Quality System specialist;

35+ years of experience; 22 years as an FDA expert investigator, trainer and policy-maker.



Martin Browning,

President and Co-Founder,


  • 22 years as an expert FDA  investigator and trainer

  • Co-author of FDA's Quality System Regulation -- the QSR (21 CFR Part 820)

  • In-demand Quality System auditor, advisor and trainer for device-makers worldwide

Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).


At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other organizations.


Here's what other students say about this course

and the course instructor:


"This was one of the best courses I have attended -- it was exactly what I needed!"


"These are great training courses which have already helped me with my job. Thanks very much!"


"The experience the instructor shared with great knowledge was great. The class was very informative. I truly enjoyed it."


"Informative and well-organized course. As a new RA/QA manager, this is a wonderful foundation for learning and helping my team. Thank you!"


"Well run and provided the depth I've been searching for."


"The instructor was truly fantastic. Her real-life experience, sense of humor and vast subject knowledge made this one of the best training classes I've attended."


“EduQuest has really helped us expand our quality system beyond ISO/IEC 17025 to the FDA requirements. We are much more confident in meeting our FDA needs! We are able to speak the language now as well. Even though everyone wanted to be told exactly how to do things, EduQuest was able to get across that we have to implement the regulations for ourselves and DOCUMENT why! ‘If it’s not documented, it doesn’t exist’ has become a constant quality slogan around here.” (Quality Manager, Blacksburg, VA)


Latest Schedule of Course Dates:


QSR Compliance Basics:

Complying with FDA's Medical Device 21 CFR 820 Quality System Regulation

On-site, on-demand training is available when and where you need it


This course can be delivered directly at your facility, when and where convenient for you and your colleagues. For details, email EduQuest.




EduQuest: EDUcation: QUality Engineering, Science and Technology   +1 (301) 874-6031