Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel

Teachers
Michael Drues
Category:
Med Device/ Regulatory & Compliance/ Introductory Courses/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Without a solid understanding of the regulatory requirements surrounding medical device development, non-regulatory professionals are not thoroughly prepared for how the process can impact clinical trials, approvals, and go-to-market strategy. Understanding how regulations impact device development (and learning to communicate more effectively with regulatory professionals) will help avoid problems before they occur.

This seminar will demonstrate important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities.  All medical device pathways to market are presented with a discussion of the advantages and challenges of each.  Multiple examples of products on the market, under development, and on the drawing board (including videos) are presented in an interactive format.  Strategies for using regulation as a competitive advantage will be discussed.

LEARNING OBJECTIVES

Using the case study approach, participants will gain a working understanding of:

  1. What is and is not a regulated medical device?
  2. How are medical devices classified?
  3. What are the different pathways to market and how do I decide when to use each?
  4. What does the future hold?

Who Should Attend

WHO SHOULD ATTEND

Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the regulatory requirements surrounding medical device development.  It is also designed for those coming from the pharmaceutical or biotechnology worlds and now working on medical devices as well as those working on combination products. Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all benefit from this webinar.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Drues
Works regularly for the FDA, Health Canada, the US and European Patent Offices, and other regulatory and governmental agencies worldwide.

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