Quality Management Systems for Medical Devices

The cornerstone in the efficient manufacturing of a medical device is the implementation of a quality management system. Medical Device companies are required to develop a QMS that conforms to the regulations imposed by the FDA and ISO 13485 to ensure the safety of a medical device on the market.

This course will provide an in depth look into the FDA Quality System Regulation (21CFR820), and International Standard ISO 13485 for Quality Management Systems. You will also learn the related aspects of Risk Management and Medical Device Reporting.

Topics include:

• Design, Document , Production and Process Control
• CAPA
• Risk Management
• Medical Device Reporting

Practical Skills:

• Understand what a Quality Management System is
• Understand how a Quality Management System works practically in a Medical Device company
• Understand the elements of a Quality Management System and how they work together
• Know how to design an FDA/ISO compliant Quality Management System
• Know how to development a complete set of Quality Management System procedures
• Know how to implement an appropriate Quality Management System for a Medical Device company

Note: Prerequisite:

• Overview of Regulatory Affairs for Medical Devices
• and/or
• Previous work experience

Course Number: BIOL-40323
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices

+ Expand All

4/1/2024 - 6/10/2024

$745

Online

Closed

• SECTION ID:

  180613

• 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.

• INSTRUCTOR:

  Moyna, Colleen

• TEXTBOOKS:

  No textbook required.

• POLICIES:

  No refunds after: 4/8/2024.
  

• NOTE:

• DATE & LOCATION:

  4/1/2024 - 6/10/2024
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.