Gain a working understanding of regulatory affairs for medical devices, IVDs, and software as a medical device (SaMD) in the United States in this intensive, one-day online workshop.
Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating medical devices and products. They will review audits/inspections, regulatory pathways, and the future at FDA, as well as compliance and enforcement requirements. The speakers will also cover US Food and Drug Administration (FDA) guidance and options and strategies for FDA submissions
Registration Fees & Deadlines
Present - 04 October 2025 Early bird: Member: $440 | Nonmember: $520
October 5 - November 4, 2025 Regular Member: $520 | Nonmember: $610
Learning Objectives
By the end of this event, participants will be able to:
- Understand the basics of medical device, IVD, and SaMD classifications and the key regulatory pathways, including 510(k), de novo, and PMA, to help navigate early-stage regulatory decisions.
- Grasp the fundamentals of FDA inspections and postmarket compliance, including how to prepare for audits, navigate the inspection process, and respond effectively post-inspection.
- Learn the core principles of design control and quality management systems (QMS), ensuring compliance from product development to postmarket surveillance.
Who Should Attend?
This workshop will benefit individuals who are new to the regulatory profession, entering the medical device industry, or changing companies and/or product lines or industry. The material will also be helpful to anyone studying for the RAC-Devices exam.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Tentative Schedule/Agenda:
- FDA Breakdown & QMSR Overview
- Audits & Inspections
- Design Controls
- Medical Device Classifications & Submissions
- Specifics of IVDs & LDTs
- Clinical Investigations
- Labeling & Ad Promo
Speakers
Etienne Nichols
Head of Industry Insights & Education, Greenlight Guru
Sara Adams
Senior Medical Device Guru, Greenlight Guru
Chris Rush
Solutions Enginner II, Greenlight Guru
Christie Hughes
Principal Consultant, Qserve Group
Eric Henry
Sr. Quality Systems & Compliance Advisor, King & Spalding
Vernon Baker
Senior Medical Device Guru, Greenlight Guru
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.