FMEA Software for Medical Devices

General Information
  • Expert guidance for Failure Mode and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA)
  • 32-bit FMEA tool optimized for Windows® 2000/NT 4/2003 Server/XP
  • Stand-alone and network license configurations
  • Easy-to-read Microsoft® Excel-type Worksheet
  • Integrates with Microsoft® Visio®
  • Graphing tools make it easy to create 2-D and 3-D line and bar charts as well as Pareto Charts
  • Data analysis tools provide insight about high-risk areas of design, process, application and service
  • FMEA study comparisons help to standardize documentation by identifying inconsistencies
  • Open architecture allows users to adapt template structures for unique corporate methodologies
  • Revalidation strategies for self-auditing of FMEA studies
  • Enhanced security features for data entry, version control, and change tracking
  • Online links and attachment capabilities for drawings, PDFs, Microsoft® Excel spreadsheets, etc.
  • Timed Backup and Auto Recovery features guard against loss of data

Administrative Record Keeping
  • Maintain detailed records about sessions, team members, drawings and more
  • Supports regulatory requirements for an auditable trail
  • Version Control
  • Quick set up time for studies
  • Double authentication feature enhances document security by requiring passwords re-entered to approve a working document

Ease of Use
  • Data Mirroring allows you to enter data simultaneously in multiple areas of your study
  • Creates Diagrams within the software
  • Advanced Data Check alerts you to missing information and data entry errors
  • Enhanced autotype / copy from features for quick and efficient data entry
  • State-of-the-art graphical user interface aligns with Microsoft Window XP™ interface design
  • Multiple formatting allows users to customize formats for multiple worksheets
  • Insert pictures to individual cells in worksheet to ensure effective visual aid is added to support your study
  • Zoom feature allow you to effectively zoom in or out during your study
  • Drag & Drop between Microsoft Excel® and Word®
  • Unlimited Undo & Redo features
  • Update Template allows user to update existing files (data) to modified master template
  • Thumbnails of attached diagrams visible in data cells

Risk Ranking
  • Industry–standard and customizable Severity (S), Occurrence (O) and Detectability (D) Rankings
  • Pop-up windows containing risk ranking scales make it easy to record S, O and D values
  • Automatic Risk Priority Numbers (RPNs) calculation
  • User-definable equations for Risk Priority Numbers

Recommendation Management
  • Cost analysis based on estimated and actual recommendation costs
  • Multiple date tracking fields (Start Date, Completion Date, Revalidation Date)
  • "Places Used" Tracks the location of recommendation(s) throughout the study

Knowledge Based Libraries
  • FMEA-Med comes loaded with libraries of failure modes for heat and temperature, mechanical, and pressure, as well as an extensive failure effects library
  • Create new libraries specific to your designs, processes, applications and services
  • Convert old studies into libraries to retain and use legacy data

Reporting / Exporting Data
  • Generate "Web-ready" HTML reports
  • Insert corporate logos into headers and footers for detailed, professional and customizable reports
  • Multiple, individualized reports can be quickly created from the same study
  • Export to Microsoft® Word, database, PDF and spreadsheet formats
  • Batch File export