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Regulatory Writing for Medical Devices

This course provides a basic introduction to regulatory writing for medical devices. Participants will learn how to write documents which will be able to meet internal and external stakeholder expectations. Through lectures, discussions and hand-on exercises, participants will learn the best practices for regulatory writing.

Upcoming Virtual Courses

Regulatory

Regulatory Writing for Medical Devices (August 2025)

Aug 12 to Aug 14, 2025

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Overview

Through lectures, discussions and hand-on exercises, participants will learn the best practices for regulatory writing. By the end of this course, participants will have gained the knowledge and skills necessary to effectively write documents for either QMS compliance or for product safety and effectiveness.

Objectives

Over the course of six (6) hours, the attendee/participant will be able to:

  • Recognize importance of medical device documentation 
  • Construct documentation which conveys the intended message 
  • Differentiate the content between document types 
  • Identify the stakeholders involved in using medical device documentation 

Who Should Attend?

Instruction is targeted at professionals directly involved in writing documentation either for the QMS or for product safety and effectiveness. To maximize your learning opportunity, we recommend this course for beginning or intermediate professionals.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.