Greenlight Guru said today that it has added updates to the change management capabilities of its medical device quality management system (MDQMS).
The update was designed to improve traceability and efficiency associated with product and process changes, according to the Indianapolis-based company. It includes advanced workflow efficiencies to identify, assess and track the items affected by change orders while ensuring connectivity and traceability to records or sources that influenced design or process changes within the system. The update also allows customers to track and trend the effectiveness of their change activities with analytics and key performance indicators.
Issues associated with medical device changes, both process- and product-related, represent a significant source of noncompliance for medtech manufacturers. Changes require updated documentation, approvals and signatures across teams and, depending on the complexity of the device, across multiple departments, as well as clearly stated justification and desired outcomes for each change.
“We know change is inevitable with highly competitive medical device manufacturers changing rapidly in the pursuit of higher quality and, as medical devices become increasingly commoditized, in response to consumer demand for new features,” said Greenlight Guru CEO David DeRam in a news release. “Modern medical devices require modern solutions to everyday workflows.”
“Paper and digital-paper based systems, such as spreadsheets and file hosting sites, can only get you so far once serious changes start being made to a medical device,” added Jon Speer, company founder and VP of quality assurance and regulatory affairs. “Quality management systems shouldn’t get in the way of innovation; we’ve improved our change management capabilities to make high device quality possible through the QMS, not in spite of it.”