Today’s medical device companies are moving, changing, and adapting at an incredibly rapid pace.
They are preparing for changes and updates to regulations, like EU MDR, and navigating an increasingly digital world that introduces growing demands for innovation, business continuity, and operational flexibility.It is tough for organizations to keep up with these expectations, while also managing internal changes.
Too often, medical device companies find themselves being held back by inherited quality solutions and old ways of thinking and doing. These same organizations are forced to fly blind in a complex environment while undergoing pressures to balance speed, high quality, and low costs.
We believe that medical device companies have the processes, traceability, and visibility into their quality system to stay ahead of changes. We assume they have the quality data and tools necessary for making quality decisions.
The hard truth is that change is very seldom predictable or preventable; in fact, it’s inevitable. Contrary to many beliefs, most medical device companies lack visibility and find themselves working from a reactive state, waiting for mistakes to happen because of siloed information and missed items.
This sets teams up for significant inefficiencies that lead to multiple change orders or inconsistent and incomplete changes being made to processes and product lines, putting compliance at risk while adding enormous personal stress.
To make matters worse, quality systems have been designed to make your quality data work against you, instead of for you, turning change management into a daunting task for teams.
While 60% say they rely on traceability for conducting changes, 28% of medical device professionals say it still takes a full day to run a change impact analysis.
This proves change to be a tedious and error-prone process of identifying all of the documents and quality artifacts impacted by a proposed change order. It requires either encyclopedic knowledge of the quality management system or a labor-intensive, manual search through a heap of files to find connections.
No longer do organizations have to put compliance at risk by changing or referencing multiple change orders during an audit. More often than not we find ourselves stuck in the ebb and flow of change—waiting and reacting to the impacts of change on the product line(s), policies, procedures, and other areas of the organization. This type of reactionary response sets teams up for significant inefficiencies and compliance risk while adding enormous personal stress.
It’s time to stop reacting to change and to start predicting its impact.
The dark ages of quality and change management are over. It’s time for an intelligent QMS solution that supports a shift to a new reality: predictive quality.
the world’s first AI & machine learning recommendation engine for medical device quality
Today we unveil Halo℠ for Change Management, a revolutionary technology that will transform the way you manage change by embedding new artificial intelligence (AI) and machine learning (ML) capabilities into your workflow to create efficiencies and improve quality across your change management process.
Halo℠ for Change Management leverages AI and machine learning algorithms that are engineered to predict the immediate and downstream impact of any proposed change as well as provide actionable recommendations that will transform your change management process.
This helps users mitigate the risk of missing documents or areas impacted by a change while controlling speed, quality, and costs across the entire change process.
Here’s how Halo℠ for Change Management helps you get changes done right the first time around and keeps your company moving forward...
AI-powered recommendations that mitigate risk and improve quality
Eliminate anxieties about whether you've missed something in your change orders.
When creating a change order, Halo℠ for Change Management leverages AI and machine learning algorithms to identify documents, product development artifacts, and quality processes impacted by a change.
Know what documents and items you need to pay attention to by receiving a vetted list of items to review and add those key elements to your change order with confidence that all connections are accounted for and included in your request.
Halo℠ for Change Management reduces the risk of human error and avoids rework with updating or executing a change by making your QMS work for you.
AI and machine learning capabilities to identify documents, product development artifacts, and quality processes impacted by a change.
Receive a curated list of recommended documents, design artifacts, and quality events to assess the impact of a change and add to your change order.
Accept or dismiss recommendations and provide proactive feedback on items specifying reasoning for when a change is needed or not.
Reduce the risk of human error and avoid rework in making an update or executing a change; eliminate wasteful spend on rework or recalls.
Real-time visibility into the impact of a change
Prevent working from a reactive state in which you’re waiting for mistakes to happen because of siloed information, labor-intensive searches, and missed connections.
With real-time visibility into the impact of a change, you’re able to understand where a policy, procedure or other quality artifact is used across different processes or referenced throughout your QMS.
Effortlessly combine cross-functional knowledge and information to provide full visibility and traceability throughout the change management process, and say goodbye to manually sifting through data from different teams (manufacturing, quality, product development, etc).
Seamlessly demonstrate closed-loop traceability and impact of a change in an audit with confidence that you are making constructive changes based on data-driven decisions that will ensure you’re staying ahead of issues before they happen and keep your team on track.
Understand the connectivity and context of the recommendations and actions to take based on a change.
Uncover the down-stream impact of a change, required updates, and recurring trends in your quality data
Visualize the relationships within your QMS to understand the connectivity and context of the system recommendations
Make more informed decisions on a much smaller subset of data
It’s a new day for Greenlight Guru: a new product, introducing new solutions for new efficiencies in your processes, all powered by our AI recommendation engine, Halo℠.
It’s time to bring quality out of the dark ages and say hello to the new world of predictive Quality. See the power of Halo℠ for Change Management →
Looking for an all-in-one QMS solution to advance the success of your in-market devices that can integrate your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →