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[…] for development. The collaborative elements of the Comment Stream feature helps distributed engineering teams communicate critical changes to each other as part of their daily operations. For example: Einride develops features at a fast pace, often enhancing the functionalities of their electric freight vehicles after they’re deployed. Teams need to react fast and change tracks if […]
[…] acquisition. So what is Jama Connect’s role in this? Jama Connect is the platform where the questions in the RFI are built, collaborated on, and optimized. For example, below is a screenshot of a sample Jama Connect project where we have the user requirements and a set of potential RFI questions. By using Jama […]
[…] point. Without such guidance, there will be wide variance in the breadth, depth, and fidelity that each member of the team builds into the system model.” For example, a switch in a system is expecting the command “On” but for some reason receives the command “Start.” The switch will not function. The “On” and […]
[…] may not be used until years later when the product is being transferred to manufacturing and being commercially distributed. A few of these other processes include non‑conforming materials, device master record, product change control, and complaint management. Thus, purchasing a full eQMS system earlier than necessary results in paying for functionality that may not […]
[…] and how investigators are trained. Involve your SMEs so they are prepared as well. Records to review include those associated with the particular device of focus. For example, in a Pre-Market Approval (PMA) inspection, ensure an SME can walk an investigator through the Design History File of the device to demonstrate the design controls […]
[…] to be able to deliver some quick wins to the organization shortly after project kick-off. The typical place to start is the painful and time-consuming after-the-fact traceability efforts. For example, continuous syncing between requirements and software development task management in Jira or Azure DevOps can be set up quickly to automate traceability from requirements to user […]
[…] of additional consensus standards and guidance documents, including – ANSI/AAMI/IEC 62304: Medical Device Software – Software Life Cycle Processes Off-The-Shelf Software Use in Medical Devices Provision of Examples (Documentation Level, System and Software Architecture Diagram Chart Examples) RELATED: Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management Let’s analyze each […]
[…] one way or bi-directionally, and the frequency with which changes are synced. Updates can flow as fast as every 15 seconds, so both systems always have the latest information. For this particular scenario, I’ve configured Interchange so that when development work is complete in Jira, the user story status is automatically synced back to […]
[…] rejection or needs a revisit, and as a moderator, I can actually see and manage the whole review center within a single tool right through here. For example, we highlighted this particular area and Carleda had some interesting comment here, but that’s a single point of comment. A more interesting one is one that […]
[…] a hazard. Situation – According to ISO 14971, the concept of risk combines two variables: the probability of harm and the severity of harm. Risk – For example, if a particular hazardous situation is very likely to cause harm and would be very harmful if it actually occurred, then it would be a high […]