Tele: 561.316.3330
Breaking Medical Device News

Wednesday, October 20, 2021


HomeGreenlight GuruGreenlight Guru Announces Enhancements to Medical Device Quality Management Software Platform

Greenlight Guru Announces Enhancements to Medical Device Quality Management Software Platform

Greenlight Guru, the only medical device quality management system (MDQMS) software platform, is announcing the release of the Fall 2019 platform update, which includes enhancements to risk and document management, as well as a new in-app resource center.

Highly complex medical devices may have dozens of identified risks and hundreds of documents and records to manage in order to maintain ISO13485, ISO 14971 and 21 CFR Part 820 compliance. For users of paper and intranet-based quality management systems, managing these activities presents unique issues for searching, sorting, tagging and navigating vital records, resulting in inefficient workflows and risk of moved or deleted files.

“Quality management systems have long been thought of as a necessary evil, a dumping ground for regulatory records and documents, and not as the product improvement tool they can be,” said Jon Speer, founder and VP of QA/RA at Greenlight Guru. “The Fall 2019 release of our MDQMS platform focuses on a significantly enhanced user experience that makes a quality-first workflow so simple and intuitive that development teams can begin improving their device quality from day one.”

The Fall 2019 release has numerous platform enhancements that include:

  • Updated Risk Management tagging functionality, resulting in more intuitive searching and sorting.

  • Advanced Document Management functionality that enables inline PDF Views in order to allow teams to quickly view any uploaded or system-generated PDF artifacts, as well as enhanced search, sort, navigation, and document sharing capabilities.

  • New dashboard functionality that allows employees to have quick visibility into updated and actionable tasks across product development projects and quality management activities

  • Additional in-app tips and personalized guides for power users and new hires alike to quickly get the most out of the platform.

In addition to these updates making that further simplify the ability for medical device companies to quickly produce documents needed by auditors and regulatory organizations, these tools allow a new level of flexibility that encourages product development teams to achieve quality in a workflow that works best for their team.

“Fines and penalties from regulatory agencies compounded with the expense of lost trust and market share from recalled medical devices can be devastating for medical device manufacturers,” said David DeRam, CEO of Greenlight Guru. “If you think compliance is expensive, try accounting for the impact poor device quality can have.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy