ISO 14971 Software Validation File

Qualification of IT systems used to ensure quality and medical-device design is essential. This follows Article 4.1.6 in ISO 13485:2016 as well as European and FDA directives. To help our customers save time when building and maintaining their validation files linked...

The Arkema Starmap Tool: A Worldwide TDC Sécurité Rollout

Discover the standard version of TDC Sécurité Arkema, the global leader in speciality materials After branching off from Total over 15 years ago, the French company Arkema is currently the leader of speciality materials with over €7.9 million in turnover and 20,000...

Block Boundary Diagrams: A Solution Using SysML?

Next demonstration of our FMEA software An introduction to the block boundary diagram The AIAG & VDA FMEA Handbook, published in June 2019, explains how to set up a Design FMEA analysis using seven steps. Structure analysis, Step 2, depicts the architecture of the...

Easy-to-Read and Coherent Inspection Procedures with Your FMEAs

Robust Manufacturing Suite helps you create easy-to-read, illustrated inspection procedures for immediate access by operators in their working languages. As expected, these inspection procedures share pertinent data with the FMEA database, control plan, work...

Parameter Diagram (P-Diagram)

The P-Diagram is a graphic tool created before a project in addition to the product’s functional analysis. The P-Diagram appears in the AIAG 4th Edition manual. In 2020, the AIAG & VDA FMEA Handbook also presented this tool and proposed a variant to...

FMEA Action Plan

Management of FMEA action plan is the foundation of the continuous improvement process, and we have integrated it into our FMEA tool. The action plan is integrated with the same database as the FMEA charts, control plan, manufacturing flow chart, inspection...