Question: Is this a product lifecycle management (PLM) system?
Answer: Greenlight Guru is an industry-dedicated quality and product development platform
to accelerate the delivery of life-changing medical devices. The Greenlight Guru platform currently supports Quality Management System (QMS) processes medical device companies must demonstrate for regulatory approval and compliance, including design control, risk, document management, training management, and project management processes.
Question: When you change the user requirement does it flag all the risk that is tied to it?
Answer: With Greenlight Guru, when you change a user requirement, it provides traceability of all changes. It is not going to flag it in a way it is red in color but it will have that traceability.
Question: Some people want to build their product strategy where they have accessories or where they need to support certain products as accessories. How do you handle a design history file (DHF) in Greenlight?
Answer: Greenlight Guru provides you the ability to have living DHF projects with all associated inputs and documentation. You can create as many DHF projects as needed to manage your design controls for multiple products, including any products you define as “accessory” products.
Question: How do you handle the risks that don’t trace to harm?
Answer: The FDA or any regulating body will want to see what are the harms that can come out of your device. In each case, with Greenlight Guru, if you identify a risk you can manage those risks, even if it does not trace to a harm.
Question: Is there a way to see progress with risk and DHF completion?
Answer: Yes, in Greenlight Guru, you can easily track progress through risk management views, DHF visibility, and analytics to see where you are, and collaborate on reviews and work.