Webcast: RAC (US) Exam Preparation Series (2016) – Medical Devices I & II

Starts: Jul 27, 2016 12:00 (ET)
Ends: Aug 3, 2016 13:30 (ET)

Webcast Titles/Dates:

27 July: Medical Devices I	12:00-1:30pm ET
3 Aug: Medical Devices II	12:00-1:30pm ET

Passing the RAC exam takes hard work and a lot of preparation. As part of a complete study plan for the RAC (US) exam, this popular webcast series can help, particularly with the exam’s analysis and application to the workplace components. This RAPS webcast series will provide applications and examples to help you expand your practical knowledge and put strong foundational knowledge to use.

The live webcasts include interactive Q&A sessions with subject matter experts covering select topics. This also is a great opportunity to ask questions and clear up any areas of uncertainty you have about the exam.

Plus, you get free access to the recordings for an entire year, so you can revisit the information and make sure you get the most out of it—as many times as you need to.

Learning Levels: Basic, Intermediate

Who Should Attend?

Those who have registered or plan to register for the RAC (US) Exam
Regulatory professionals of all levels wishing to expand their knowledge

27 July

3 August

History of Regulations
Regulatory Framework for Devices

What is a medical device
Who regulates medical devices
Classification/reclassification
How to determine classification
General controls
Special controls for Class II devices
Premarket approval for Class III devices

Regulatory Submissions

Premarket notification 510(k)
De novo
Investigational Device Exemption (IDE)
Premarket Approval (PMA)
Expedited Review
Humanitarian Device Exemption (HDE)

Agency Interaction
Quality System Regulation
Labeling Requirements
Postmarket Surveillance/Medical Device Reporting (MDR)
Recalls, Corrections, and Removals
Promotion and Advertising
Import/Export
In Vitro Diagnostics (IVD)

More information