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Course

Overview of Regulatory Affairs for Medical Devices

BIOL-40322

The healthcare industry is dynamic and full of exponential growth. In this innovative and regulated industry, it is essential for medical device professionals to understand the business, science and regulations in developing a medical device from concept to commercialization.

In this course students will develop an understanding of the regulatory affairs environment, how to navigate and work with the FDA; and the steps and timetable to develop and commercially market medical devices in the United States. It will also highlight post market compliance issues once a device has been commercialized.

This course is designed for individuals new to the medical device and biotechnology industries or who are considering a career in Quality, Regulatory Affairs or Project Management. Professionals employed in research and development, bioengineering, quality, regulatory, law, sales and marketing who are seeking a more comprehensive picture of the medical device regulatory process will also benefit.

Topics include:

  • Working with the FDA
  • Device Classifications
  • Product development/approval process (IDE, 510(k), PMA)
  • Post-market controls
  • State and federal site inspections
  • Enforcement activities
  • Universal Device Identification
  • International Marketing

Practical Skill Development:

  • Understand the Product Development Life Cycle
  • Preparations for State and Federal Inspections
  • How to work proactively with the FDA and California State FDB
  • Understand International Regulations

Course Information

Online
3.00 units
$745.00

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This course applies to these programs

Regulatory Affairs for Medical Devices

Course sessions

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Section ID:

186469

Class type:

Online Asynchronous.

This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

Textbooks:

All course materials are included unless otherwise stated.

Policies:

  • No refunds after: 4/7/2025

Schedule:

No information available at this time.
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Instructor: Jennifer Mascioli-Tudor

Jennifer Mascioli-Tudor
Jennifer is an experienced leader, who brings more than 20 years of industry experience in Quality and Regulatory leading global teams within the pharmaceutical and medical device industries. She has an extensive background in leadership and global quality assurance, regulatory affairs, and operational excellence.
 
Jennifer has progressed through several roles of increasing leadership responsibility working for companies such as Johnson and Johnson, Medtronic, Nevro, American Medical Systems, Boston Scientific, Outset Medical and GE Healthcare. She is passionate about building energized, diverse, and inclusive teams that are motivated by a shared mission to transform healthcare.  She is now Founder and CEO of JMT Compliance Consulting (www.jmtcompliance.com) where she is focused on working with small, emerging growth companies to drive Quality/Regulatory strategy and Organizational excellence.
 
She holds a B.S. in Physiology/Chemistry and French from Eastern Michigan University and an MBA, Global Management from the University of Phoenix.  
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