10 QMS Musts for SaMD and Devices Featuring Software (and how to best utilize for product & team success)

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:

• Procedure setup,

• Software safety class or level of concern,

• Requirement management,

• Risk management,

• Design reviews,

• Verification and validation,

• Release management,

• Change management,

• Configuration management, and

• OTS/SOUP management.

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.

Specifically, this webinar will cover:

• 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

• Q&A session

Who should attend?

• Regulatory Affairs Professionals & Management

• Quality Professionals and Management

• Software Development Engineers and Management

• Medical Device Executives

• Clinical Affairs Professionals and Management