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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)


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