Articles and publications about Risk, Quality, Design & Innovation

What is blended learning? Blended learning is a “mixed / blended” training process integrating: Live training with the trainer: either in remote or on-site sessions E-learning sessions on a dedicated online platform: Rise Up or your platform   Offer your collaborators...

As of September 2019, EURO-SYMBIOSE and KNOWLLENCE are joining forces to offer a solution adapted to the new AIAG-VDA FMEA standard. EURO-SYMBIOSE & KNOWLLENCE: two complementary entities EURO-SYMBIOSE supports its clients in their search for efficiency and...

Everything you want to know about our trainings… without ever daring to ask! You will find below the answers to the most frequently asked questions about our training catalog… If you can't find what you're looking for, don't hesitate: contact us!You want to know more?...

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...

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 studied system with the two recommended...

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 supplement the...

For Regulatory Affairs Departments to Manage medical device risks under ISO 14971:2019 and Automatically generate risk management reports RM 14971 is a Medical Device Suite database module.An ISO 14971 program with integrated reference documents This ISO 14971-based...

A great opportunity for the automotive industry & complex systems ​The AIAG FMEA 4th Edition reference manual has been the guide used by many industries for several years now. In June 2019, the USA-based AIAG and the German VDA published a handbook with an...

ISO 26262 is based largely on IEC 61508. Updated in 2018, the standard addresses safety in onboard electrical and electronic systems for road vehicles. Complying with ISO 26262 means setting up a process related to ensuring quality (or ensuring safety) and a safety...

Generic studies? Saving time during design and process? Begin by reusing what you already have! Knowllence tools are here to help in managing generic studies. (An informative video is available for current customers with online access)Cumulative generic studies: Save...

  As a part of our partnership with EURO-SYMBIOSE, the FMEA experts of our two companies worked together in order to warrant you a common understanding of the new AIAG-VDA handbook and to synchronize our best practices. The FMEA software by Knowllence is...

ISO 14971:2019 Medical Device Suite helps you analyse your risks under ISO 14971: Medical Devices — Application of Risk Management to Medical Devices. This standard has been revised, and the newer version, ISO 14971:2019, was published in December 2019. The standard...

To implement ISO 14971:2019 within Medical Device Suite, the RM 14971 module offers a solution for managing the different variants of a product within the same family/range that allows you to perform only one risk analysis for all your medical device variants and...

The synergy between Knowllence and Bassetti China is one more time effective! From 6th-7th of November, BASSETTI as one of the sponsors of this event is delighted to give a speech about "FMEA Software solution compliant with the new AIAG & VDA Standard". Thomas,...

We can't really say that FMEAs are very loved by some teams... If you don't have fans of FMEAs... There are ways to work around the problem!Some companies have not yet implemented preventive analyses of their manufacturing operations. Some people openly declare...

Robust Manufacturing Suite is the new name of our TDC Process FMEA software, because it does much more than just Process FMEA studies! Software Solution for Quality in Manufacturing: Involve all teams in a motivating making up of lean management and FMEA methodology...

TOOL CHARACTERISTICS TO SUPPORT ALL LIFECYCLE STAKEHOLDERS' REQUIREMENTS IN COLLABORATIVE ENGINEERING DESIGN par Maria Paz Claros Salinas, Guy Prudhomme and Daniel Brissaud 3S Laboratory, University of Grenoble, BP 53, 38041 Grenoble cedex 9 DET06, Setubal, Portugal,...

By Samuel Gomes, Davy Monticolo, Vincent Hilaire (UTBM) and  Benoît Eynard (UTT) . International Journal of Product Developpement, 2007. Click here for a pdf version:  codekf_IJPD_07t Abstract: Collaborative design methods and tools are increasingly integrated...

By Davy Monticolo, Vincent Hilaire , Samuel Gomes , Abder Koukam, UTBM Abstract: An approach to manage Knowledge based on multi-agents System using a Ontology This paper presents a knowledge management experiment realized in an industrial company. Our research...

By Davy Monticolo, Vincent Hilaire, Abder Koukam et Samuel Gomes, UTBM. This paper presents a knowledge management experiment realized in an industrial company. Our research concerns the development of a project memory to capitalize Information and Knowledge created,...