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...
Blog for Design Manufacturing
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...
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...
Medical Device Software Validation File
Medical Device Software and Computerized System Validation The Medical Device Software solution is developed by Knowllence in accordance with a Computerized System Validation (CSV) process.This process is designed to demonstrate that our solution — the "computerized system" — is reliable and meets the expected requirements. A validation file consists of a set of required documents that certify the quality of either Medical Device (MDS) software or tool software (used during the product...
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...
How can you achieve ISO 26262 compliance?
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 plan. The goal of the 12-part standard is to reduce safety risks to an acceptable level. The ISO 26262 steps using Robust Engineering Software Robust Engineering Software makes incorporating these functional safety steps at the...
Cumulative generic studies: How can you save time with your new products?
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 time when designing new products Across the board, development cycles seem to be shortening. New products need to be launched within 18 months, rather than three years as before. So that design teams can handle these reduced...