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We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.
The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
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The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.
Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.
The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.
Easy to upload, organize, and find documents
Change management refers to the way a company manages modifications to products and processes within their medical device business. Change can come about for a number of reasons, and we refer to these as triggers for change.
Many events can trigger a change throughout the lifecycle of a product or organizations, including:
New or modified products, as well as any subsequent change to those products
New or modified processes for how you conduct business as you right-size and grow your QMS
New or modified controlled documents, such as templates, work orders, forms, etc., as well as any subsequent revisions made to those documents
New products, processes, or controlled documents all require change management practices be put in place. A change can involve modifications to records and procedures in your design controls, or your device master record (DMR).
You might find yourself needing to do additional validation on a device, or maybe you are changing suppliers, which requires changes to associated documents and procedures.
The purpose of a change control process is to manage changes in the QMS, preserving internal consistency within the system by ensuring that updates to important documents are reflected everywhere those documents are used. The change process should also include an element of approvals, ensuring that major changes to the QMS are reviewed by multiple stakeholders before implementation.
Regardless of where you choose to market your products, your medical device company must establish and maintain a quality management system (QMS) to ensure that they are safe and effective for the end user. Quality management systems undergo constant change throughout the life cycle of your product, and managing that change effectively is one of the most important functions of the QMS.
When implementing a change control process, medical device companies need to ensure that they are meeting the change control guidelines as required by the FDA QSR. A formalized change control process ensures that your organization is performing process validations, conducting approvals and producing change records when required. Here's what to include on your change control documentation:
Medical device companies that effectively monitor the inter-dependencies of documents in their QMS will have an easier time identifying documents that are affected by a change and maintaining consistency within the quality documentation.
The FDA quality system regulation (QSR) known as 21 CFR Part 820 makes reference to several types of changes that medical device companies should manage through a formalized change control process:
The EU Medical Device Regulation (MDR) covers the requirements specific to design changes in several different contexts, including:
Obtaining a CE marking certification is a straightforward process, but you'll have to invest time and resources in preparing your company for a third-party audit by a notified body.
Here are the 8 steps you must follow to obtain CE marking certification for your medical device:
ISO 13485:2016, the globally harmonized standard for medical device quality management systems, covers what's required of manufacturers when it comes to the control of design and development changes:
Section 7.3.9. Control of design and development changes. The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.
The requirements are nearly identical as those found in FDA's QSR, whereas prior to implementation all design and development changes shall be:
When reviewing any change, manufacturers should always use a risk-based approach to evaluate the impacts of that change on other quality subsystems and processes.
Manufacturers must produce and maintain records showing proof of all change reviews and activities leading up to final approval and implementation.
Greenlight Guru Change Management software enables medical device companies to link or connect any documents or configuration items that are stored in the quality system.
This simplifies the change management process, increasing the visibility of inter-dependencies between change records, documents, risks, design controls, customer complaints, audits, non-conformance reports and more.
When a specific document needs to be changed, Greenlight Guru makes it easy to quickly determine what other documents are affected and automates the approval and record-keeping aspects the change control process.
Greenlight Guru Halo℠ for Change Management is the first predictive recommendation engine for medical device companies to easily make the shift from reacting to changes to predicting changes.
Halo℠ for Change Management is powered by artificial intelligence (AI) and machine learning (ML) technologies to create efficiencies and improve quality across the change management process.
These new capabilities work in tandem with those of Greenlight Guru Visualize to provide medical device companies with a network view of the entire quality system with real-time visibility into the impact of a change on connected policies, procedures, and artifacts in a single, closed-loop quality system environment.
Gain control of your change process by leveraging Greenlight Guru Change Management Software, the only QMS software solution designed exclusively for medical device companies.