Manage your complex medical devices in the only design control matrix that provides the flexibility you need to manage an n-level hierarchical matrix of components and sub-components within an innovative and elegant user interface.
Focus individual resources on the right components so they can appropriately apply their efforts while not holding up the entire project. Provide transparency and maintain control of the project to ensure each and every component receives the attention needed while focusing on the quality of the device as a whole.
See your device's design in a single, enhanced view.
Visualize the connections throughout your device requirements and QMS to better understand the shared relationships between items. See shared specifications across components and have insight into manufacturing or supplier issues.
Easily navigate between test reports and protocols to your design control verifications and validations, while also seeing related design inputs, risk controls, and components.
Create and update your traceability matrix in minutes, not hours or days. With Greenlight Guru, you can create your design control objects, link complex configurations, attach related documents and link any object within Greenlight Guru with a single click.
Wasting employee hours and paying expensive consultants for low-value activities is no longer required. Specialized teams can use google-like and deterministic search, components, groups and tags to search and filter the components to see the information that is important and relevant just to them.
Easily plan, conduct, and document your design review activities with actionable feedback.
Versatile enough to align with your existing product development methodology, Digital Design Reviews give you the flexibility to include individual Design Controls or components at different stages of development across distributed teams.
Eliminate cumbersome processes for documenting design reviews by bringing your design review process online with Part 11 compliant approval workflows and artifacts which are automatically included in your Design History File.
The Design Control led approach to managing the development of medical device software applications & components.
Enable product development teams to leverage the agile functionality of Jira while maintaining traceability to Design Controls processes throughout the device lifecycle.
Streamline and even automate the management of reports, matrices and other documentation needed to develop your product and prove regulatory compliance.
When you manage these activities manually, you spend thousands of dollars on consultants you don’t need, your employees waste time on these low-value activities and you slow your time to market.
Many medical devices include some type of software in the device. Industry standards define that the software components be managed separately just like the hardware and software components of traditional medical devices. Manage each individual module or component of a software component or device through its own design workflow and ensure that each component is reviewed and approved as part of the whole.
Stop wasting time searching for the required documentation when trying to compile your DHF.
With Greenlight Guru, you can produce all of the documents needed at each stage of production and generate your DHF at any time.
Provide your team a centralized workspace.
Push your product forward and meet aggressive deadlines by providing a centralized workspace where everyone can see each other’s updates in real time. Now, your team can stop wasting time chasing signatures, searching through multiple email threads and dealing with messy design transfers.
Provide auditors and inspectors with the signatures and objective evidence they require - on-demand.
No more chasing down lost or missing records. They leave impressed, you bring the audit to a close and you don’t walk away with observations, 483s or warning letter.