Blog for Design Manufacturing

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 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...

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...

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...

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...

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...

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...

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...

As a part of our partnership with EURO-SYMBIOSE, the FMEA experts of our two companies worked together in order to warrant you a common understanding of the new AIAG-VDA handbook and to synchronize our best practices. The FMEA software by Knowllence is customized to be in perfect match with the EURO-SYMBIOSE training and assistance. The goal if of course to facilitate the deployment by our Clients. Training and software are both available in french and english, the best way to harminize...

ISO 14971:2019 Medical Device Suite helps you analyse your risks under ISO 14971: Medical Devices — Application of Risk Management to Medical Devices. This standard has been revised, and the newer version, ISO 14971:2019, was published in December 2019. The standard now provides additional information on the terminology linked to applying risk management to medical devices. It also expands on risks/benefits and post-market surveillance.ISO 14971:2019? Knowllence’s Tool Our Medical Device Suite...