Blog for Design Manufacturing

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, and full traceability, this module constitutes an essential foundation. The Functional Analysis module of Medical Device Software enables you to: Structure requirements and clarify specifications secure the design efficiently...

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 S95b committee allows us to engage within a dynamic network and contribute directly to the development or clarification of new standards. As a result, our Medical Device Software is always closely aligned with standardization principles, helping our clients work with...

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 will discover definitions, uses, and examples, written by our expert consultants specializing in the digitalization of FMEA and risk assessments. The illustrations are taken from our Robust Engineering Software solution, which...

Medical Device Software is a powerful tool that helps evaluate and optimize the safety and effectiveness of medical devices, while ensuring compliance with ever-evolving regulatory requirements.Normative Evolution: XP S99-223 (French medical device standard on benefit-risk and safety management.) To provide a useful and easy-to-use web solution, Knowllence keeps a close eye on medical device standards. One of these is the experimental standard XP S99-223, which was updated in December 2023....

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...

What are the CSRs "Customer Specific Requirements" in the automotive industry? Customer Specific Requirements (C.S.R.) are requirements specific to each carmaker or OEM (Original Equipment Manufacturer) in agreement with the supply chain. They guide OEMs and subcontractors in the automotive sector to guarantee customer satisfaction. CSRs form specific contractual requirements applicable to all products delivered to the customer, in addition to the requirements included in the specifications of...