Medical Device Suite proposes optional software for functional analysis (needs, technical) and for Design and Process FMEAs.

Doodles, Triangle, time, money, quality

Capture the customer voice, the needs and the internal constraints, identify and analyze the failures on design and on process.

To start your projects on a robust basis, a structured innovation and design process need to be setup. Numerous technical data management and PLM solutions exist. Medical Device Suite feeds them with clear and complete data through proven methodologies, such as functional analysis, FMEAs or Fault Tree Analysis:

  • TDC Need captures the voice of the customer and structures the “actual” need using functional analysis
  • TDC Structure crosses needs and technical breakdown structure or optimizes the (re-)design with SADT or block diagrams
  • TDC FMEA deals with the Design FMEA and/or Process FMEA studies, control plans, manufacturing synoptic overview, job description…
  • TDC FTA handles Fault Tree Analysis

Medical Device Suite offers by default the approaches that stem from standards, expertise and best practice in numerous industries in more than 20 years accompanying the industry actors.

Quality for design and manufacturing of Medical Device.


See also how to manage your ISO 14971 Risk Analysis

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Our team remains at your entire disposal for any precision or to schedule a demonstration when you want.

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