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.”