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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Design Control Training for Medical Devices: Requirements and Best Practices

Design controls are integrated management practices applied to the medical device development process, ensuring that the resulting device is safe, effective, and meets stakeholder requirements. The pace of change and the iterative nature of most design processes makes understanding when and how to apply design controls even more important.

In this 3-day class, you’ll learn strategies and best practices for managing these processes, thus ensuring that your organization’s devices meet user needs, intended uses, and specified regulatory requirements, including MDSAP (Medical Device Single Audit Program).

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Francisco Area, CA 04/16/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 05/07/2019 3 $2895.00 Add to Cart CONTACT US
Boston, MA 06/04/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 06/25/2019 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 07/23/2019 3 $2895.00 Add to Cart CONTACT US
Edison, NJ 08/27/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 09/17/2019 3 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 10/08/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 10/29/2019 3 $2895.00 Add to Cart CONTACT US
Boston, MA 11/19/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 12/03/2019 3 $2895.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Identify design control requirements related to FDA, EU MDR, MDSAP, and ISO 13485.
  • Describe the design review, design verification, and design validation processes.
  • Evaluate the links between design, usability, and risk management. 
  • Understand the pros and cons of the linear and iterative processes and the approach to systems design.  
  • Identify strategies for risk-based sampling and statistical justification. 
  • Describe best practices for the design transfer process. 
  • Practice the design control process in workshops, building a design history file (DHF). 
  • Describe postmarket surveillance and input to design changes. 
  • Identify FDA requirements and MDSAP outcomes and linkages related to the design and development process in preparing for audits.

Who Should Attend

Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, and regulatory, as well as anyone else who has a role in building a robust regulatory-compliant environment. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.

Number of Days: 3
CEUs: 2.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

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