Belonging to Medical Device Suite, our FMEA software allows to organize, automate, and capitalize all data concerning your medical device in terms of Design and Process FMEA studies, flowcharts, job instructions, etc 

FMEA Software :  Both Standard and Customizable

Our FMEA software offers all you FMEA types within the same software license: Design FMEAs, Process FMEAs control plan, process flowchart, action plans, job description and special characteristics.

You can choose to do only one type of FMEA (i.e. FMEA Process) or to chain in a consistent and integrated way Design and Process FMEAs.

In addition to the standard proposed in Medical Device Suite, this FMEA software module can be fully customized (within 1-3 days) to your habits and working methods, both at the level of interface (charts, sills, quotations,…) and at the level of printings and related documents : FMEA study, control plans, follow-up to the critical characteristics matrix, etc.


Exemple de tableau AMDEC Produit sur un dispositif médical

Methodological Coherence of the MD Design Process

The methodological consistency is ensured through the sharing of knowledge within a single database between different tools throughout the design process of your medical device,from needs to process:

  • Within the  FMEA software: between Design FMEA, Process FMEA, Control Plan, etc…
  • In the comprehensive approach design from external functional analysis, technical functional analysis and then risk analysis: FMEA shares data with
  • FMEAs and Preliminary Risk Analysis are the entry point for fault tree Analysis (FTA) ,
  • Occurrence statistics   and links to the causes of process dysfunction can be retrieved from your SPC solution, in order to enrich your  Process FMEA  studies.

Gains of time and ROI

Our customers testify they get significant gains of time (up to 50%) in the realization of FMEA studies, in the 10 months after the software training. Improvement of rigour in the approaches and in the follow-up of actions promote also the use of the FMECA method, which becomes a real productivity tool. It considerably improves the image towards increasingly demanding customers.
The FMEA software allows the operational management of the action plans through E-mails and facilitates the monitoring of measures implementation.
FMEA studies are so standardized for all project teams, which allows better efficiency, facilitated reuse, and a coherent image towards customers.
Tree items are displayed with a (modifiable) color code according to the sills of criticality. Thus, you can instantly target points to work as a priority.

Capitalization of Your Medical Device FMEA studies

You can create cumulative generics, which will enrich themselves with new projects. It becomes easy to create repositories for your enterprise. Thanks to the data traceability this will remain perennial and reliable: you can identify by a simple right click the origin of the relevant data, and therefore decide its integration (or not) in your project.

  • You can constitute libraries of effects, mode, cause, etc., as needed, these libraries are linked together Your FMEA studies are thus always using the same technical vocabulary and rigour is facilitated by these proposals.
  • You can of course at any time complement, enrich these libraries – if you have rights.
  • You can create comprehensive design and Process FMEA studies coming from generics, with all the links already declared between the 2.

Action plans

  • FMEA software of Medical Device Suite offers an easy tracking of actions with filters, reports, email and reminders.

Control Plan of Medical Device

Being managed within the same database, control plans are at any time in coherence with Process FMEA, and with product characteristics. Any difference between FMEA and Control Plan  generates an alert.

Production Overview and Work Instructions

Our FMEA software enables of course too to manage flow diagrams and job instructions, to ensure the implementation till the industrial  workshop.



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