RAPS Twin Cities Chapter: Design Controls According to 21 CFR 820 and ISO 13485:2016: Recorded Presentation and “Ask the Expert” Chat Session

Join colleagues from your local regulatory community for a new and innovative way to learn about quality management systems from a subject matter expert and one another. The RAPS Twin Cities Chapter is recording a presentation on Design Controls, which can be accessed at your convenience, and hosting an online “Ask the Expert” session with the presenter. Can’t make the live session? No problem, the entire discussion will be archived for you to access later. (Check out the “How Does It Work?” tab below for a detailed description.)

All medical device manufacturers supplying medical devices to the US are required to maintain a quality management system in compliance with Part 820 the Code of Federal Regulations (CFR) Title 21 (21 CFR 820). Quality management system requirements cover a broad range of areas, including production and process controls, corrective and preventive actions, product development and management.

The ISO 13485 standard is an effective solution to meet a quality management system’s comprehensive requirements. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU medical device directives, regulations and responsibilities and demonstrate a commitment to medical devices’ safety and quality.

This webcast is based on the 21 CFR 820 Quality System Regulation and ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes and will explore the design control elements of design inputs, design outputs and design verification.

After viewing the recorded presentation, attendees will understand:

  • Design input requirement categories and qualities
  • The relationship between design input requirements, design output and design verification
  • Design verification basics
  • Tools and techniques to support new product development

This activity is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. RAC holders may claim one RAC recertification credit.

  • At a Glance
  • Agenda
  • Speaker
  • How Does It Work?
  • Registration Info
  • Cancellation

At a Glance


Thursday, 12 October 2017 (12:00-2:00 pm CDT) 


Regulatory Exchange Online Community

RAC Credits:

1 RAC certification credits upon completion of the program 

Registration Fees:

RAPS Members: $20
List: $35


Thursday, 12 October (12:00-2:00 pm CDT)

Ask the Expert Session
Regulatory Exchange Online Community


Tiea Theurer, MT(ASCP), MPA, lead auditor, TUV Rheinland North America Group 

How Does It Work?

  • Registrants will be subscribed to a Regulatory Exchange online community (log in instructions will be provided).
  • The recorded webcast will be viewable and downloadable from the community library.
  • Watch the recorded webcast at your convenience prior to the 12 October online chat session.
  • Post any questions for the presenter on the discussion board of the community and engage with others that have viewed the webcast.
  • Log in to the community on Thursday, 12 October between 12:00-2:00 pm CDT, to engage directly with the presenter and others for the live chat session.
  • Access to the recording and the online discussion posts will be accessible for one year.

Registration Info

RAPS Members: $20
List: $35

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Local contact: Lena Cordie, chair, RAPS Twin Cities Chapter
RAPS contact: Wesley Carr, senior program manager, chapter and volunteer relations





Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.