Greenlight Guru extends its solution to further integrate quality and product development activities

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Our Medical Device Success Platform and new Greenlight Guru product addition do just that. It enables medical device companies to create, evolve and innovate on their products without worrying about siled and disconnected data.

Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP), today announced the launch of Greenlight Guru Products. This new workspace and functionality will help medical device product development teams better control ongoing product development. This includes creating bills of materials (BOM) and connecting product information to their design history file (DHF) and quality actions, all in one place.

Today, disconnected tools and data silos present a risk of common errors in product development that increase costs, delays, and compliance risks when bringing a device to market. This can divert a team’s attention from innovative design to tedious paperwork and information management.

With Greenlight Guru Products, teams can easily manage product and component information with full traceability to streamline work for faster submissions and continuous improvement. This creates a seamless flow between the product development and DHF processes. To help teams manage critical components of their Device Master Record (DMR) while ensuring traceability throughout the entire product lifecycle.

“We found in our 2022 industry benchmark survey that 70% of employees in development roles believe medical device innovation is driven by investing in the right solutions and resources that support design and development,” said Brandon Henning, vice president of Product at Greenlight Guru. “Our Medical Device Success Platform and new Greenlight Guru product addition do just that. It enables medical device companies to create, evolve and innovate on their products without worrying about siled and disconnected data.

Greenlight Guru Products enables teams to create and manage parts, multi-level BOMs, and product families throughout medical device design. They can link product information within Greenlight Guru and take advantage of full traceability with engineering change management as designs change and evolve.

“The fact that we can create product families and use item types across products and across product families is very helpful,” added Adam Cargill, QA/RA/CA Manager at MediView. “The Greenlight Guru products will allow us to track the components of our devices with traceability. Having the ability to create a BOM connected to Greenlight Guru rather than trying to manage it outside of the system or in a Word document/Excel sheet is wonderful.

Medical device professionals who implement Greenlight Guru products can continue to focus on innovation rather than paperwork, resulting in continued product development through commercialization. Learn more about Greenlight Guru products by visiting https://www.greenlight.guru/Product-Management-Software.

This publication follows the announcement of Genuine 2022 quality, the must-have experience for medical device managers, quality and regulatory professionals who drive innovation in the most successful medical device companies. To learn more about sponsorship opportunities, click here, or to register for the True Quality 2022 tour https://www.greenlight.guru/true-quality.

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About Greenlight Guru

Greenlight Guru is the only Dedicated Medical Device Success Platform (MDSP) designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies compliance with FDA and ISO regulations, and provides a single source of truth by connecting the management of all quality processes such as CAPAs, risks, audits, etc Greenlight Guru’s platform is used by thousands of organizations around the world to go beyond basic compliance and achieve true quality for their medical devices. For more information, visit http://www.greenlight.guru.

Media Contact

Naomi Gollmer

[email protected]

(419) 518-0067

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