Medical Device Suite proposes optional software for functional analysis (needs, technical) and for Design and Process FMEAs.
Quality in Design and Manufacturing of Medical Device
How to 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, 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.
How to Manage also Your ISO 14971 Risk Analysis ?
Medical Device Suite is a range of modules. “RM 14971” is the software dedicated to Risk management according to ISO 14971:2013 that facilitates work :
- Medical Device Data are structured and shared in a common database with Regulatory Affairs
- Access are secured, adapted to each role
- The methodology suits the context: FMEA and / or EN ISO 14971 risk analysis.