Over the decades, the automobile has become more reliable and safer despite the widespread use of on-board electronics and the gradual arrival of autonomous vehicles. This success is also the result of the standardization of operational safety methods, which has led to the emergence of international standards. These include: Updated in 2018, ISO 26262 specialized in the safety of EE (Electronic and Electrical) systems Functional Analyses and FMEA In its 2019 edition, the AIAG FMEA & VDA...
Blog for Design Manufacturing
Blended learning: easier training
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 more autonomy Your training, at your own pace No more need to schedule XX synchronous sessions Better monitoring of skill improvements Check the training level Follow and monitor the trainees’ improvements Adaptation of the...
EURO-SYMBIOSE and KNOWLLENCE are partners for FMEA
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 performance improvement. Training on standards, methods and tools has been part of the company's DNA for over 30 years. For its part, KNOWLLENCE, software editor in the field of risk management and design methodologies, has a recognized...
Training: FAQ and best practices
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? Contact us! If you want to know more about our services and you do not have yet a dedicated sales representative, contact us at +33 (0) 381 382 950… Or fill out the contact form by clicking here, and we will call you back within...
Managing Medical Device Variants: A Single Risk Analysis for Each Product Family
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 models!Standardization is not always possible in design as you might need to produce an entire range of medical device variants that can adapt to different markets, situations, or body types.Certain issues require reflection when...
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 to the software program, we provide the turnkey version of Medical Device Suite’s RM 14971 module with a corresponding validation file.This file contains all of the documents required to demonstrate the quality of the medical...
Block Boundary Diagrams: A Solution Using SysML?
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 tools being tree structures and boundary diagrams. A tree structure represents the hierarchy between the system, subsystems, and components. The boundary (or block) diagram goes into deeper details about the relationships between...
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 supplement the functional analysis process. This article focuses on the original approach when designing a product.Why is the P-Diagram important? A parameter diagram challenges the preconceived notion that an ideal function fully converts...
RM 14971 Assists in Compliance with ISO 14971:2019
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 management risk software integrates contents from reputed references. It is based on the contents in the ISO 14971, ISO 62304, ISO 62366, and ISO 24971 standards, as well as the practical guide published by the members of the...
The AIAG & VDA FMEA Method: Handbook and Software
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 aligned, structured approach for both methodologies during the FMEA development process. The goal of correlating these FMEA methods was to make working with subcontractors easier and to control the cost of quality (COQ). The new AIAG...