The Medical Industry
The medical sector includes those in the medical field, medical device manufacturers, and pharmaceutical companies. This segment is unique because of their direct human intervention and contact, and also due to strict governmental regulations that are a fundamental part of the industry. The medical industry has to comply with FDA regulations and requirements in the US, as well as the regulations and compliance directives of other countries. In addition to these compliance requirements, the medical industry is concerned with liability issues, as well as overall risk reduction, the elimination of human error, and tight process and procedural controls.
The Relyence toolset can be a key part of reliability and quality objectives in the medical field with the following analysis modules:
Relyence Fault Tree
Fault Tree Analysis (FTA) is a well-known, often-used risk assessment tool that can be utilized for all types of risk analysis and management. Relyence Fault Tree provides a comprehensive graphical fault tree diagramming front end with an accurate analytical back end for best-in-class fault tree analyses (FTA). Supporting exact calculations, simulation techniques, importance measures, and minimal cut set evaluation, Relyence Fault Tree is the comprehensive solution for fault tree analyses. Learn more.
Failure Mode and Effects Analysis is used throughout the medical sector, and is often a standard requirement for clients in this market segment. Supporting SAE J1729, ARP 5580, AIAG, as well as custom FMEA implementations, Relyence FMEA supports Design FMEAs and Process FMEAs. Relyence FMEA includes out-of-the-box functionality that gets you up and running in minimal time in a streamlined, easy-to-understand worksheet interface. RPN (Risk Priority Numbers) as well as other criticality assessments are available. Additionally, Relyence FMEA incorporates a high-level dashboard for system wide overview of your FMEA activities. Learn more.
Relyence FRACAS / CAPA
Supporting Corrective and Prevention Action requirements, Relyence FRACAS offers out-of-the-box support for your corrective action processes, and is completely adaptable to meet your unique requirement. With built-in support for process control through workflow, enforcement of approvals, and notifications, Relyence FRACAS ensures your processes remain tightly controlled, manageable, and measurable. With high-level dashboard overviews, Relyence FRACAS can track vital metrics and events to keep everyone informed. Learn more.
Relyence Reliability Prediction
Supporting MIL-HDBK-217, the worldwide-accepted standard for failure rate analysis, Relyence Reliability Prediction allows you to quickly and accurately perform your reliability analysis, including MTBF and failure rate values of components, subsystems, and systems. Learn more.