The development environment for medical devices with embedded software is challenged by increasing amounts of software and related documents/work products (which is in turn increasingly complex and modular), heavy regulation (by the FDA and other agencies), distributed development teams (across companies and continents) and a constant time-pressure. Traceability across multiple product lines and multiple software systems will rapidly become time-consuming and prone to error if development and change control is not properly managed and aggregated.
View this on-demand Webinar and learn how MKS Integrity addresses these challenges with a configurable application lifecycle management solution that is based on best practices gleaned from real implementations. You’ll see how MKS Integrity delivers full traceability across multiple product lines and variants, drives high levels of quality and leverages reuse and automation to reduce time-to-market. Product demonstrations will show how the MKS solution enables complex reports like the Device Master Record (DMR) and Design History File (DHF) to be created with mouse-clicks (instead of person-weeks), providing the ability to accelerate development cycles while ensuring compliance with FDA and other regulations.