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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

Can't travel? This class is also available virtually.

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) 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 (PM) 09/14/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 10/12/2020 5 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 10/13/2020 3 $2995.00 Add to Cart CONTACT US
Boston, MA 11/10/2020 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 12/15/2020 3 $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.

In-Person 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.

Training Schedule

This training is delivered as five 3.5 hours sessions.  Each session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

A typical public seminar schedule for this class would run:

Monday 1:30 PM – 5:00 PM
Tuesday 1:30 PM – 5:00 PM
Wednesday 1:30 PM – 5:00 PM
Thursday 1:30 PM – 5:00 PM
Friday 1:30 PM – 5:00 PM

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

We may also from time to time offer sessions that run daily from 8:30 AM to 12:00 PM.

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.

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that require a final exam are extended by 2 hours 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.

Get answers right now. Call 1.800.472.6477

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