TDC Need captures the voice of the customer and structures the “actual” need using functional analysis and printing Functional Performance Specifications.
A Formalized and Standardized Approach
Need software to ask all the right questions at the start of a “Medical Device” project, ignoring solutions, through the comprehensive functional expression of the need.
The proposed functional analysis approach is based on the European standards EN 1325-1, French NF X 50-151, and APTE® method. The Need module of Medical Device Suite may be useful in support of design process, value management or consultations of suppliers, with automatic printings.
It will also allow you to standardize and organize the capitalization of your functional performance specifications (FPS).
Easy Management of Needs Changes
Traceability is handled on each of the data concerning your medical devices: use phases, functions, performance criteria,… Thanks to the knowledge of all detailed changes, user can for example filter data that has been changed since the last project review or list successive changes on a particular performance.
Improvement of reactivity in Medical Device projects
Used in video projection, TDC Need facilitates the reflection of project team, through the various tools: environment method, matrix of completeness, crossover sort. The live changing on functional tree can save a lot of time, and thus improve the effectiveness of meetings. In addition to the simple printing of documents, it is possible to share the charts of function characterization and the actions to perform, in order to gain in reactivity between sessions.
Consistency of methodological data of Medical Device Design
The methodological consistency is ensured through the sharing of data between various tools throughout the process of your medical device design:
- within the same database: with TDC Structure for technical functional analysis ( functional block Diagrams / SADT and FAC), with TDC FMEA for studies Design FMEA, Process FMEA, monitoring Plan, etc and then if necessary to TDC FTA for fault tree analysis…
- by interfacing with other software: requirements management, statistical process control (SPC), action plan management, Tolerancing, Manufacturing Process Management (MPM) or any internal specific development .