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Event Registration - The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

Start Date:
Monday, December 09, 2019
End Date:
Friday, December 13, 2019
8:00 AM - 12:00 PM Eastern Standard Time

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices­­-Application of Risk Management to Medical Devices.

This is an updated version of our previous Quality System Requirements and Industry Practice course. Included are important developments in world-wide medical device regulations and revised standards, specifically 13485 and the International Medical Device Regulators Forum Medical Device Single Audit Program (MDSAP).

An optional exam is available online for two weeks following the end of the program.

Registration Fees:

  • AAMI Members: $2985
  • Nonmembers: $3285
  • Government Employees: $1150



Program Outline


DAY 1 | 8 AM-5 PM 
Overview of FDA Quality System Regulation and ISO 13485:2016 – 3 hours
Management – 3 hours 
Document Controls and Records – 2 hours

DAY 2 | 8 AM-5 PM 
Design Controls – 8 hours 

DAY 3 | 8 AM-5 PM 
Acceptance Activities – 3 hours 
Production & Process Controls – 5 hours 

DAY 4 | 8 AM-5 PM 
Production and Process Controls – 2.5 hours
Monitoring and Feedback – 5.5 hours 

DAY 5 | 8 AM-12 PM 
MDSAP – 2 hours
FDA Inspectional Approach/QSIT – 2 hours



Program Objective

Upon completing this program, participants will take home the knowledge to examine their quality management system to determine if it complies with both FDA Quality System requirements and 13485 requirements and recognize where improvements are needed. Participants will learn about the FDA inspectional approach and the Medical Device Single Audit Program. This course will empower the attendee with the knowledge to successfully host a FDA/MDSAP audit.


In addition, this course covers best practices, recognizing that different approaches may apply to various medical device classifications and to company size. This course is the one stop resource for learning industry best practices in implementing a QMS that meets global requirements.


Target Audience

Instruction is targeted to professionals directly involved in meeting both FDA and international quality system requirements or those who are ultimately responsible for compliance, including harmonization with 13485. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of a quality management system.



A combination of situation analyses, case-study exercises, review of sample recall and warning letters, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.




Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.

  • Event Location
    • Address:
      AAMI Center for Excellence (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
  • Hotel Info

    • Course Location: AAMI Center for Excellence (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
      Phone: (703) 525-4890

      For further information about the hotels near AAMI, transportation, and local attractions, please visit the AAMI website at Hotel Reservation Information

  • Event Notes
    • Substitutions, Transfers, and Cancellations. . . In the event you are unable to attend this course, you may transfer your registration to a qualified colleague or apply your registration fee to a subsequent program, on a space-available basis. All substitution, transfer, and cancellation requests must be made in writing to AAMI Customer Service.

      Send a colleague to attend in your place . . . Substitutions can be made at any time prior to a program without penalty. No substitutions will be honored once a program begins.

      Transfer to a subsequent program . . . AAMI allows a one time transfer to a subsequent program as an alternative to cancellation. Transfer requests must be received by AAMI in writing (via e-mail or fax) no later than one week prior to the start of the originally registered program. (Please note: for those requests received within one week of the program, AAMI will assess a $400 transfer penalty in addition to the registration fee). Transfer requests must state alternate name and date of the program choice. Since programs are not all priced identically, the registrant is responsible for any increases in registration fees resulting from the transfer. No refunds for the difference between program prices will be made should the price of the program choice be less than the price of the originally registered program. Any request for a transfer beyond this one-time allowance will be treated as a cancellation (See Cancellation Policy).

      Cancellation . . . If AAMI receives a cancellation request at least one week prior to the program date, the registration fee minus a $400 cancellation fee will be refunded. No refunds will be granted for cancellations received by AAMI less than one week before the program.

      No Shows . . . Failure to attend a program for which you are registered will result in forfeiture of registration fees.

      AAMI Membership . . . Are you entitled to the member discount? Please call (800) 332-2264, ext. 1214, before you register and find out. If you are not a member, join AAMI for a special rate of $250 for an Individual Membership and $310 for an International Individual Membership to receive a discount on your registration fees.

      Course Confirmation . . . Confirmation notices will be distributed one week after your registration has been processed. You must have this confirmation to ensure course attendance.

      Contact Information . . . Your contact information will be provided on an attendee roster that will be distributed to course attendees and faculty. If you do not want your telephone number, fax number, and e-mail address provided to course attendees and faculty please email AAMI Customer Service. (This does not apply to AAMI's on-line membership directory.)

      Note . . . Please confirm course availability prior to submitting payment and making travel reservations. AAMI is not responsible for any airline or hotel cancellation fees if course availability is not confirmed prior to making travel reservations.

Registration is closed.