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FMEA Software for Medical Devices
FMEA-Med™ 7 is the most comprehensive and innovative software tool for conducting a Failure Mode and Effects Analysis of any manufactured medical product. And now with the release of Version 7, Dyadem has taken this software to a new level!

FMEA-Med is an all-in-one product that drives corporate consistency while dramatically cutting the time required for studies. The goal of this product is to assist you in preventing patient injuries, costly product recalls, and down time in your production department.

The release of Version 7 will help you complete your studies up to 50%+ faster. Plus, it will help you identify more risks than ever before - ultimately creating safer products!

This specialized Failure Mode and Effects Analysis software also has numerous features that make it quick and easy to record information, generate quantitative risk data, and create HTML and PDF reports. The predefined hierarchy immediately gives structure and focus to your study, and the built-in libraries of failure modes and potential causes aid you in quickly entering data in the FMEA Worksheet. FMEA-Med stands out from generic products, such as accounting spreadsheets and word processors, which were never specifically designed for risk analysis studies. You can even open your existing studies that were completed in Microsoft® Word or Excel, edit your data and then create reports.

Features in Version 7

Feature list includes the following:

  • Microsoft® Visio® integration
  • Microsoft® Word export capabilities
  • Attachment of corporate logos into reports
  • 2-D and 3-D graphing tools for line and bar charts
  • Data analysis tools for identifying high-risk areas
  • Document control and collaboration with Microsoft SharePoint®
  • Advanced Data Check
  • Failure Mode and Effects Analysis study comparisons

Regulations Governing Medical Device Manufacturers
The software fully supports the following regulations:

  • ISO 14971
  • EN Standards
  • 510K / Pre-market Notification
  • ISO Standards
  • MIL-STD-1629A
  • GMP / Good Manufacturing Practices

In short, FMEA-Med is the most time-efficient and cost-effective tool for conducting a Failure Mode and Effects Analysis of medical equipment. The software delivers a substantial return on investment over manual transcription or generic spreadsheet programs.

If your organization is looking to buy FMEA / FMECA software, you can download a free trial version of FMEA-Med that includes all of its features and functions.
FMEA-Med Methodolgoy and Software Training

Course Description
This course teaches all the material from the FMEA-Med 7 software training course and adds key Failure Mode and Effects Analysis methodology training as well. Many popular methodologies will be discussed and taught to participants. This learning intensive course will focus primarily on the various types of Failure Mode and Effects Analysis, 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).

Course instructors are industry experts from the fields of risk management and assessment, chemical engineering, engineering design and development, and projects execution.