Developing a software as a medical device (SaMD) requires timely synchronization of software development processes with procedures and requirements under a QMS.
And if you intend to implement agile practices in your software development, you may find they seem to contradict the regulated process for developing a medical device.
The purpose of this webinar is to walk you through the best practices for setting up an ‘agile QMS’ which can be adapted and optimized concurrently with your SaMD development phases.
The topics we plan to go over include:
Software safety class or level of concern,
Verification and validation,
Configuration management, and
This free, in-depth webinar will be presented by Kyle Rose of Rook Quality Systems who will provide a detailed explanation of the aforementioned QMS functions, as well as the cross functional collaboration methods you can use to benefit your product, QA/RA, and engineering teams.
QMS procedures for a SaMD project
Why Software Safety Classification and Level of Concern are so critical
How to best manage SaMD releases and configuration management
How to ensure good communication among cross functional teams
Regulatory Affairs Professionals & Management
Quality Professionals and Management
Software Development Engineers and Management
Medical Device Executives
Clinical Affairs Professionals and Management
Greenlight Guru is the only medical device quality management system (MDQMS) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.
Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more.