Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Intermediate Medical Writing: Medical Devices [2.0 RAC]

2.0 RAC Credits Member: $255.00 Nonmember: $350.00
Intermediate Medical Writing: Medical Devices [2.0 RAC]
Regulatory writing is an integral part of the product development and approval process and plays a crucial role in speeding product submission and supporting compliance.

This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, including key sections of the Premarket Approval (PMA) and 510(k) Premarket Notification applications for medical devices. You will be introduced to the components of each of these documents and learn techniques for improving document quality in order to advance your career as a regulatory writer.

At a Glance
  • Target Audience: Professionals with one to three years’ experience in regulatory writing and those who need a basic introduction to the regulatory documents discussed.
  • Learning Level: Basic
  • Total Length of Course: 2 Hours
  • RAC Points: 2

Learning Objectives

Upon completion of this course, participants should be able to:
  • Describe key sections of the PMA and 510(k) Premarket Notification applications
  • Formulate a plan for preparation of these documents
  • Identify appropriate resources for further guidance

Lesson Titles
  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification

Enrollment Period: 12 months
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