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Course

Design Control for Medical Devices

BIOL-40324

Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices.

This course will provide a detailed and practical overview of the design control process for medical device design and development. The course will cover design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and labels. The course will also cover related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).

Topics Include:

  • Initial Design Control Process
  • Design Output Process
  • Verification and Validation
  • Design Transfer
  • Tagging, Tracing, Packaging and labeling
  • Risk Analysis

Practical Skill Development:

  • Understand the overall Design Control process
  • Understand the (10) elements of Design Control
  • Know how to apply each element of Design Control to the most common design disciplines
  • Know how to do Design Risk Analysis
  • Know how to do tracing between Risk Analysis, Design Input, Design Output, Design Verification and Design Validation
  • Know practical methods for Design Transfer and Design Review

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

Closed

Section ID:

190466

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: 6/30/2025

Schedule:

No information available at this time.
Closed

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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