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Design Control Training for Medical Devices: Requirements and Best Practices

Available as a virtual instructor-led seminar.

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 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) and the EU's new Medical Device Regulation.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 11/08/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 01/17/2022 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 03/28/2022 5 $2995.00 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.

Virtual Class Days

  • 5 consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time
Virtual Half-Days: 5
In-Person Full-Days: 3
CEUs: 2.5

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Virtual Class Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

Tablets and mobile devices may lack some essential functionalities and are not recommended.

See course dates to find / register for a virtual session of this course.


Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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