LED Dental’s engineering department has recently adopted a powerful medical device requirements management software package called MatrixALM produced by Matrix Requirements (matrixreq.com), an ISO 13485:2016 certified software development company. LED plans to integrate it into all its product development and engineering projects moving forward.
The software allows users to create various levels of stakeholder and product requirements, specifications, tests etc. and establish relationships or “traces” between them. This helps to ensure that customer and other stakeholder needs are turned into a complete set of product requirements and specifications to properly drive the medical device design. It also helps ensure that medical devices produced at the end of the process are appropriately tested and validated. Good requirements management is not only a cornerstone of good product development but is also an integral part of design control which is a regulatory and quality system requirement for medical devices.
Dr. David Morgan, LED’s Chief Technology Officer comments: “We have been looking for a powerful but easy-to-use requirements management software for quite a while and have finally found it with MatrixALM. Entering requirements, specifications and tests and establishing links between them all is completely straightforward as is integrating the required elements of an ISO 14971 compliant risk management process. In addition, the program is very configurable; it is easy to set it up the way we want and tailor it to a specific product development project. We are excited about moving forward with it. The customer support from the team at Matrix has been excellent – they are knowledgeable, eager to help and have been very responsive to all our questions.”