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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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FREE ON-DEMAND WEBINAR

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.

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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
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Hosted by

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Presenter: Kyle Rose

President, Rook Quality Systems
Wade
Moderator: Wade Schroeder

Medical Device Guru, Greenlight Guru

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About Rook Quality Systems

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.

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About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) 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.

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