Company Overview
FMEA-Med, a leading Failure Mode and Effects Analysis software solution for medical device and pharmaceutical manufacturers, helps to improve quality, productivity, and safety while ensuring compliance with strict regulations and industry standards.

Currently in Version 7.5, FMEA-Med, Dyadem’s industry leading, offers an efficient all-in-one solution that helps better analyze product designs and manufacturing processes, dramatically shorten study time, achieve more thorough studies, and prevent failures from happening in the first place. Using FMEA-Med can reduce time spent on process or design FMEA analysis by up to 65% over using a generic spreadsheet.
Features:
  • Regulatory Compliance – FMEA-Med helps organizations with the implementation of their company-wide quality, risk, and reliability programs based on regulations and standards including:
    • enhanced compliance with 21 CFR, Part 11 (regulating the use of electronic records and signatures)
    • FDA 21 CFR Part 820 QSR (cGMP)
    • Medical Devices Directive (MDD)
    • ISO 13485:2003
    • ISO 14971:2000
    • ISO 9001:2000
    • SAE J1739, ARP 5580
    • IEC 60812
  • Flexible and User-Friendly – FMEA-Med is fully configurable to meet your specific needs
    • Keeps documentation live as required for compliance with major industry quality standards
    • Accommodates various worksheets and forms related to FMEA/quality planning
    • Customizable templates that meet an organization’s specific needs
  • Knowledge-base – comprehensive professional libraries available, including fully customizable risk-ranking scales
  • Data Management and Transparency
    • Data linking features connect the different parts of your FMEA, increasing consistency across your studies by automatically replicating data in the appropriate areas
    • Linked Diagram feature provides a visual representation of data by linking worksheets to the process maps
    • List of Reference feature gives you an unrepeated list of your recommendations in a separate, pre-formatted table with references hyperlinked back to the worksheets
    • Advanced professional reporting, preformatted print reports, and auditing tools provide improved visibility into process operations
Technical Information:
  • FMEA-Med supports the following techniques: Design and Process FMEA; Hazards and Error Analysis; Healthcare FMEA; Functional, Software, Interface, and Detailed FMEA; and Process Mapping
  • 32-bit PHA tool optimized for Windows 2000/NT 4/2003 Server/XP
  • Stand-alone and network license configurations
  • Easy-to-read Microsoft Excel-type Worksheet
  • Enhanced security features for data entry, version control, and change tracking
  • Timed Backup and Auto Recovery features guard against loss of data
  • State-of-the-art graphical user interface
  • Update Template allows user to update existing files (data) to modified master template
  • Multiple, fully customizable Risk Matrices supporting capital and production losses, personnel safety, environmental release, etc.
  • Generates "Web-ready" HTML reports