Functional Analysis for Medical Device Requirements

The Functional Analysis module of Medical Device Software is a cornerstone for compliance, requirements management, and traceability in medical devices. In an environment where manufacturers must navigate innovation, strict regulatory requirements, risk management,...

AFNOR S95b Committee for Medical Device Standards

Schedule a meeting with one of our experts! For nearly 10 years, Knowllence has been an expert member of the AFNOR/S95b Medical Devices Standardization Committee, focusing on quality management and general aspects of medical devices. Our active participation in the...

Ishikawa (5M) and FMEA: complementary quality tools

The Ishikawa diagram is also known as the fishbone diagram, cause-and-effect diagram, root cause diagram, or 5M diagram. This quality tool for root cause analysis is particularly well suited for facilitating FMEA sessions and managing QHSE risks.In this article, you...

Digital Product Passport (DPP): A Transformational Shift for European Industry

KNOWLLENCE and the Digital Product Passport (DPP) The digital transformation of industry increasingly depends on the ability of organizations to structure, manage, and leverage complex technical data across the entire product lifecycle. In this context, and with the...

How to Make Your Design Robust in an Integrated APQP System

Register to: How to Make Your Design Robust in an Integrated APQP System –May 12, 2026 at 5:00 PM CEST FMEA Risks and Project Quality System Track the progress of each APQP phase and key milestone Set up alerts and notifications for at-risk milestones and deliverables...

What’s New for Robust Engineering Software (AIAG & VDA)

We are delighted to invite you to an exclusive webinar, specially designed for our Robust Engineering Software clients. Discover a summary of the 2025 updates and a preview of what’s coming in 2026! We have developed new features and improvements to: Enhance...