Design Control Requirements and Industry Practice

Program At-A-Glance

DAY ONE— 8:00 am–5:00 pm

  • Introduction to Design Control
  • Scope and Applicability
  • Design and Development Planning
  • Design Input
  • Risk Management
  • Design Output

DAY TWO — 8:00 am–5:00 pm

  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer 
  • Software Validation

DAY THREE— 8:00 am–Noon

  • Design Changes
  • Design History File
  • FDA Inspectional Approach

This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. The program has been revised to include more hands-on exercises, more "how-to" information on implementation of design control requirements, increased focus on life cycle aspects of risk management and human factors, and more up-to-date industry examples.


Upon completing this course, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet both regulatory and business requirements.


This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. During this highly interactive learning experience, participants are given ample opportunity to discuss the different approaches that can be taken depending on company size or device classification.

Who Should Attend?

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

Dates & Hotels




October 15-17, 2014 The Westin Arlington Gateway
801 N. Glebe Road
Arlington, VA 22203

Single/double rate: $215
Rate through Sept. 23, 2014
Book your room online.

December 3-5, 2014 AAMI Headquarters
4301 N. Fairfax Drive, Suite 301
Arlington, VA 22203-1633

Hotels with AAMI rates

NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline.


Course faculty are drawn from an experienced group of quality system professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders and consultants helps to ensure a balanced presentation of the design control requirements and paths to compliance.

Fee and Registration

Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.


2014 FEES

AAMI corporate & institutional members
AAMI individual members
Government employees