Solving the Quality and Compliance Challenges for Embedded Software in Medical Devices
Developing software for medical devices means managing accelerating amounts of complex and interrelated software (along with all related documents & work products). Quality is critical, cycle times are short, and everything is subject to demanding regulation by the FDA and similar agencies. The answer to these challenges is a focused application lifecycle management (ALM) solution that offers full traceability across multiple product lines and variants, drives high levels of quality and leverages reuse and automation to reduce time-to-market.
CVRx makes the Rheos® System, an active implantable technology (Class-III, FDA-regulated) for the treatment of high blood pressure. John Stroebel, Technical Fellow and Systems Engineering Manager for CVRx will share his real-world insights and experiences in using ALM to address quality and compliance challenges. CVRx has achieved complete traceability across all assets from requirements to testing and can rapidly (and easily) provide reports and documentation to meet FDA requirements. Steve Mostello 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).
Attendees will learn:
– How to generate a traceability matrix with mouse-clicks instead of person-weeks of effort
– Why using one system to manage requirements, risks, mitigations, test cases and source code leads to fewer errors and faster cycle times
– What parameterization and higher-level reuse across software assets can mean for both quality and compliance
Steve Mostello, Certified ScrumMaster and Senior Customer Solutions Engineer, MKS Inc.
Steve Mostello is a Certified ScrumMaster and a Senior Customer Solutions Engineer for MKS Inc. where he is responsible for helping clients assess, implement and gain measurable business value from Intelligent ALM (application lifecycle management) solutions. Steve has extensive experience working with Medical Device Companies, implementing solutions to improve the quality of their embedded software development while drastically reducing the time and effort required to meet FDA compliance requirements. As part of this experience, Steve led the effort to configure complex reporting that enables the Device Master Record (DMR) and Design History File (DHF) for an organization to be created with mouse-clicks instead of the person-weeks required when manually compiled.
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