FDA Regulations, Best Practices for Medical Device Design, Manufacturing, Quality and Supplier Control to Be Taught by Former Agency Inspectors July in Delaware

Tuesday, May 10, 2011 Medical Gadgets J E 4

WILMINGTON, Del., May 9, 2011 /PRNewswire/ -- Medical device R&D labs and manufacturers now have a personal resource for answers to the often confusing maze of FDA regulations outlined in the Agency's Quality System Regulations (21 CFR 820).

EduQuest - a global team of FDA compliance experts based near Washington, DC - is presenting two national training courses specifically designed for medical device quality, regulatory, engineering, and supply chain specialists this July at the Hotel DuPont here in Wilmington, Delaware (near I-95, Amtrak rail lines, and the Philadelphia International Airport). Course topics include:

  • QSR Compliance Fundamentals: Complying with FDA's Medical Device 21 CFR 820 Quality Systems Regulation (July 19-20)
  • Design Control for Medical Devices: Meeting FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing (July 20-22)

Each course is taught by instructors with personal experience conducting FDA inspections and being quality system advisors for medical device companies throughout the world. As a result, attendees receive practical guidance from those who understand the expectations of FDA inspectors and other international regulators as well as the resource realities faced by the medical device industry.

Over the past 15 years, EduQuest has trained FDA's Office of Regulatory Affairs (ORA), the lead office for all of FDA's field activities (including inspections and recalls) and Health Canada inspectors. The lead instructor is Denise Dion, EduQuest's Vice President of Quality and Regulatory Services. Denise is the former editor of FDA's Investigations Operations Manual and co-author and trainer of FDA's Quality System Inspection Technique (QSIT).

Students can attend all four days of training classes or select individual courses. Tuition discounts are available for teams of two or more attending from the same company. The courses also are available for on-demand delivery for companies who prefer to have the training delivered directly at their own facilities.

FDA medical device quality system and design control course details are available here or by calling +1 (301) 874-6031. By email, contact EduQuest.

Further Information:

Martin L. Heavner301-874-6031

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at




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