Our software and Knowllence are GDPR compliant! Since May 25, 2018, the General Data Protection Regulation (GDPR) has been in effect across all European Union Member States, giving individuals greater control over their personal data. At Knowllence, we take this responsibility seriously. Professionally, GDPR guides us to collect only the personal data that is strictly necessary, to obtain and securely store consent, and to enhance the protection and management of all data we handle. The...
Blog for Design Manufacturing
FMEA-MSR: an extension of FMEA Design
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...
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...
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! Discover Medical Device Suite Schedule a meeting with one of our experts! 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...
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. Next demonstration of our FMEA software Why is the P-Diagram important? A parameter diagram challenges the preconceived notion that...
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. Schedule a meeting with one of our experts! 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...
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 & VDA...
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. Upcoming Webinar - Demonstration of our FMEA software The ISO 26262 steps using Robust Engineering Software Robust Engineering Software makes...