Intermediate Medical Writing: Medical Devices

This course provides an overview of some of the more complex documents prepared by regulatory and medical writers, including key sections of the Premarket Approval and 510(k) Premarket Notification applications

Regulatory documents are highly structured templates, and each country has its own regulatory requirements that require the linguistic, technical, and subject matter knowledge/skills to consolidate information as per applicable guidelines, prepare regulatory deliverables that conform to the legal and regulatory requirements of specific countries (especially the U.S.), and at the same time ensure that the correct information is provided to the regulatory agencies.

This course will focus on preparing the regulatory deliverables with an overview of the 510(k) and Premarket Approval (PMA) process for launching a medical device in the U.S. market. You will be introduced to the components of each application type and gain skills for improving document quality to advance your career as a regulatory medical 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

Medical Device Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Outline the basic elements contained within the 510(k) and PMA applications

Describe and understand the contents of the PMA and 510(k)

Learn about the process of compiling and submitting a 510(k) or PMA application to the U.S. Food and Drug Administration (FDA)

Become capable of assessing whether a change needs a 510(k) or Letter to File or PMA supplement and preparing a submission if needed to ensure timely approvals and market release

Identify factors that may affect the quality of regulatory documents and understand where to seek further guidance

Lesson Titles

Lesson 1: Premarket Approval (PMA)

Lesson 2: 510(k) Premarket Notification

Lesson 3: Product Changes

Lesson 4: Postmarket Activities

This course is also included in: