Medical device quality management system debuts flexible design review capabilities for devices with multi-level design controls
INDIANAPOLIS — March 5, 2019 — Greenlight Guru, the only medical device quality management system (MDQMS) software platform, announces Digital Design Reviews, the latest enhancement of its purpose-built software designed specifically for medical device companies.
In an increasingly connected and digital world, many medical device companies still resort to documenting the design review activities necessary to demonstrate compliance in a disconnected, offline manner. This challenge is compounded for teams trying to manage design reviews across mechanical, hardware and software components at different stages in the product development lifecycle. Through collaborative feedback from both customers and industry thought leaders, the task of planning, conducting and documenting Design Reviews as required by 21 CFR Part 820.30 and ISO 13485:2016 is a common pain point that product development teams are struggling to manage.
“Design Reviews are a necessary task to ensure high device quality; however, they are a huge pain point for many product developers, especially those with multiple subsystems,” said Jon Speer, Greenlight Guru founder and VP of QA/RA. “It is our hope that, as we make Design Reviews easier to complete, we will see increased design review frequency, ultimately leading to improved device quality.”
Versatile enough to align with your existing product development methodology, Digital Design Reviews give teams the flexibility to include individual Design Controls or components at different stages of development across distributed teams. Documenting design reviews is a cumbersome process by bringing design reviews online, product development teams can leverage Greenlight Guru’s Part 11 compliant workflows and design review artifacts that are automatically included in a living Design History File. Product development teams can now focus on value-added development activities that positively impact device submissions and launch timelines without having to worry about their ability to demonstrate compliance.
Benefits of Digital Design Reviews
Simplify design review planning by quickly identifying what should be included in each design review
Streamline design review and approval processes for teams working on different subsystems at various stages of development
Drive collaboration by assuring actionable feedback is captured, documented and marked for follow up
Demonstrate ongoing compliance by automatically incorporating key design review artifacts in an audit ready, living Design History File
Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...