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FMEA-Med Methodology & Software Training

Course #205/225

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Course Description
This course teaches all the material from the FMEA-Med software training course and adds key FMEA methodology training as well. Many popular FMEA methodologies will be discussed and taught to participants. This learning intensive course will focus primarily on the various types of FMEA, including design, process, application and service. In addition, an overview of criticality analysis will be discussed with particular attention being stressed on the benefits of a Failure Mode Effects and Criticality Analysis (FMECA).

Upon completion of this course, attendees will have a vast knowledge of most FMEA methodologies and be able to confidently address the limitations and benefits of various types of FMEA studies. Attendees will also learn the significant role that team work and management plays when conducting FMEA studies. Also, current regulations governing medical devices, including 510(k)/Pre-market Notification, Current Good Manufacturing Practice (cGMP), Quality System Regulation (FDA QSR), ISO Standards, ISO 14971 and European Norm (EN) Standards, will be discussed thoroughly during the course.

Course instructors are industry experts from the fields of risk management and assessment, chemical engineering, engineering design and development, and projects execution.
Course Objective
Participants will learn how to conduct a FMEA study that meets applicable requirements as well as how to take full advantage of the features and capabilities available within the FMEA-Med software.
Course Benefits
This course will be beneficial to you and your organization for the following reasons:

  • Participants gain the ability to lead quality assurance teams by using FMEA-Med software as the documentation tool
  • The course enhances easy learning, comprehension and success through a step-by-step approach
  • Interactive learning and real world examples are used throughout
Who Should Attend?
A wide variety of professionals and organizations will benefit from taking the joint FMEA-Med software and FMEA methodology training course:

  • Any medical device manufacturer that must comply with:
    • FDA’s QSR
    • GMP/cGMP
    • EN 1441
    • ISO 9000 series
    • ISO 14971
    • ISO 13485
    • 510(k)/Pre-Market Notification
    • MIL-STD-1629A
    • European Union’s CE marking
  • Product Engineers
  • Process Engineers
  • Designers
  • Manufacturing Engineers
  • Production Engineers
  • Quality Assurance Professionals
  • Reliability Professionals
  • Design Controllers
  • Field Service Personnel
  • Marketing Professionals
  • Customer Service Representatives
Course Duration
2-3 Days - (dependent on course content) For more information on our services, training and software related to FMEA, contact us at (905) 882-5055.