Preparing to Take the RAC Devices Exam (May 2023)

RAC Credits
Virtual ProgramsVirtual Programs
Monday, 22 May 2023 (5:00 PM) - Tuesday, 23 May 2023 (8:00 PM) Eastern Time (US & Canada)

Are you planning to take the RAC Devices Exam in 2023?

Join peers from the regulatory community for a workshop and study group designed to sharpen your critical, analytical, and strategic test-taking skills.

The sessions will be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.

During the workshop, faculty will review challenge questions similar to the style and content of the RAC Exam. This style of teaching has been used in other preparatory workshops and has been determined to be most useful for those taking the RAC Exam.

Important Notes:
Participation in this workshop should not be your only method of exam preparation. RAPS provides many exam preparation materials which can help you develop a comprehensive study plan.

Registration for the Summer 2023 RAC window closes on 15 June, 2023. The Autumn testing window runs from 10 July- 18 August 2023.

Pricing Amounts & Deadlines

February 27, 2023 – April 21, 2023: Early Bird $495 Member | $580 Nonmember 

April 22, 2023 – May 22, 2023: Regular $580 Member | $680 Nonmember

Who Should Attend?

This workshop is designed for individuals planning to take the RAC Devices exam*. This is NOT a fundamentals course, and RAPS recommends attendees have a minimum of two to three years of regulatory experience and a thorough understanding of the regulatory profession.

Attendees will get the most out of this workshop if they already have a solid understanding of:

  • The full product development and lifecycle requirements for medical devices and IVDs
  • US FDA requirements
  • European regulations and guidance from the European Commission and Competent Authorities
  • Globally applicable regulatory practices, including ICH, IMDRF, WHO and ISO guidelines and standards


Day 1  

5:00 pm – 5:30 pm      Welcome and Presenter Introductions, Overview of Test-taking and Recertification, and How to Use RegEx

5:30 pm – 5:45 pm      Icebreaker Interactive Poll 1 

5:45 pm – 6:25 pm      Challenge Questions with Solutions – Round 1 

6:25 pm – 6:35 pm      Break

6:35 pm – 7:15 pm      Challenge Questions with Solutions – Round 2 

7:15 pm – 7:55 pm      Challenge Questions with Solutions – Round 3 

7:55 pm – 8:00 pm      Recap and Q&A


Day 2  

5:00 pm – 5:15 pm      Interactive Poll 2 

5:15 pm – 6:00 pm      Challenge Questions with Solutions-Round 4 

6:00 pm - 6:15 pm      Break

6:15 pm – 7:00 pm      Challenge Questions – Round 5 

7:00 pm – 7:15 pm      Break

7:15 pm – 8:00 pm      Open Forum and Q&A


Leslie Cort

Leslie Cort, RAC, PMP
Regulatory Business Process Program Manager for Global Regulatory Shared Services (GRSS), Medtronic

Leslie Cort, RAC, PMP is a Regulatory Business Process Program Manager for Global Regulatory Shared Services (GRSS) at Medtronic, where she leads functional and Enterprise-level programs and initiatives. Through-out her career, she has worked in Regulatory Affairs and supported a broad range of medical devices with experience in new product development, sustaining, international regulatory affairs and regulatory submissions.

Leslie’s educational background includes an undergraduate degree in Chemistry from Savannah State University, and a Master’s Degree from Northeastern University in Regulatory Affairs of Drugs, Biologics and Medical Devices. Leslie has served in volunteer roles at RAPS as a committee member for the RAC Devices Exam. In addition, she received the Regulatory Affairs Certifications, (US and Devices) from the Regulatory Affairs Professionals Society.

Stephanie Seidel

Stephanie Seidel, RAC
Sr. Principal Clinical Evaluation Specialist, Medtronic

Stephanie Seidel, RAC is the Sr. Principal Clinical Evaluation Specialist at Medtronic. She has over 25 years of progressive and diverse experience in the medical device industry, including 20+ years of scientific and technical communication, and 16+ years in regulatory and clinical affairs. Expertise includes Class I, II/IIa/IIb, III devices, including multi-product systems. Active and passive implantable devices, software, wireless accessories, surgical tools and electromechanical hardware. Device expertise includes cochlear implant systems, peripheral vascular, neuromodulation and blood processing devices. Authored or collaborated on 125+ approved U.S. and international regulatory submissions in over 90 markets, including for Class III (high-risk) medical devices. Senior clinical evaluation strategist for the EU, China and other global markets.

Natalie Kennel

Natalie Kennel
President, NJK & Associates

Natalie J. Kennel, FRAPS, RAC-US, ASQ CQE & CQMgr, founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs. With more than 35 years in the industry, most devoted to medical devices, Kennel has hands-on experience with development and manufacturing as well as RA/QA and clinical roles in both major and start-up medical device companies. She applies her expertise to the regulatory, quality and clinical needs of medical device companies. Since forming her consulting business in 2005, she has submitted more than forty 510(k)’s, four de novo’s, more than 45 Pre-submissions (including pre-IDEs), and several EUAs during the recent pandemic. The types of products cover both medical devices and in vitro diagnostic devices including, but not limited to, multiple orthopedic implants, intraocular lenses, infusion pumps, gynecological devices, ventilators, complex medical monitoring and neurology equipment, telemedicine devices, software-only products, molecular diagnostic systems and assays for infectious diseases, human genetic testing and oncology, various clinical chemistry and immunoassays, and point of care lateral flow assays. Recently she has worked on several CDx and CTA’s for oncology products and a novel wound care device. She has set up quality systems for several different companies. She has provided on-going RA/QA for several companies. She has prepared several international medical device submissions including for Canada, Australia, Europe, Singapore, Taiwan, and WHO. She has set up quality systems and provided regulatory affairs support for a novel tissue bank. She is actively working with several companies to prepare for the MDR and IVDR.

Kim Walker, MS, RAC (US & EU), FRAPS
Independent Global Regulatory Affairs, Quality System, and Clinical Affairs Consultant, Kim Walker Consulting

Kim Walker is an independent Global Regulatory Affairs, Quality System, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006. In her consulting practice, she assists clients with pre and post-market regulatory, clinical, and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, and start-up to large company environments. Recently, she assisted the World Health Organization (WHO) as an Innovation COVID-19 Response Team Consultant and Operations.

Kim received a lifetime membership award from OCRA in 2017 and SDRAN in 2022. She has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.


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.

All cancellation requests must be submitted in writing to  Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event. 


For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email

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