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In this blog post, we examine several different companies that have implemented Agile methods successfully and review what worked, what didn’t, and how companies can launch Agile teams that work.
In this webinar recap, we discuss the general medical device safety and performance principles of Software as a Medical Device (SaMD) development.
[…] becomes meaningful during design and development activities, not just at the end. In the Jama Connect for Medical Device Development solution, teams can use trace views and filters to make assessments about work prioritization and managing scope. For example, the solution provides visibility into: Accepted system requirements lacking subsystem requirements to make sure they are working on the right things. Subsystem requirements not tied to a system requirement to understand and manage scope. […]
[…] that ensures your team delivers the right product and avoids expensive reworks. But where should you start? In this article, we’ll explain details about SRS documents and how to use them, and we’ll provide examples to get you on the path to success. What is a System Requirements Specification (SRS) Document? The SRS document is focused on what the software needs to do and […]
[…] to traceability. If we have traceability between the artifacts in our engineering process, then we have the ability of finding the information that has an error. For example, if you’ve been working on your needs analysis, and then you start to decompose your requirements, at that stage, if there is a traceability between the […]
[…] or an autonomous vehicle. Multiple teams must collaborate, often over great distances, while numerous requirements and tests must be consistently tracked and traced. In this infographic, we examine 10 of these major challenges and how to solve them, including: Moving on from outdated legacy or document-based solutions Simplifying compliance and meeting regulations and standards […]
[…] out Part I of our ASPICE 101 blog series to learn about what the standard is and why it’s important to automotive development, and Part II, where we examine the similarities and differences between ISO 26262 and ASPICE. In this post, we take a look at the goals of ASPICE and the different compliance levels. […]
[…] together the RFP requirements with the proposal so all of the context included in Jama earlier can be leveraged for the evaluation. Proposal Submissions and Review: an Example Here’s an example of how the proposal process might look within Jama’s Review Center. In this case, the contractor’s submission meets the requirement. Here we have […]
[…] do not understand written technical requirements and would benefit from seeing a version of the product. Designed to: Collect feedback from non-technical stakeholders by showing them an example with which they can physically interact. How to: At first prototyping can be executed via storyboard, interactive screen, virtual mock-up, navigation flow, etc. The exact method […]
[…] with the greatest risk. The FDA also established classifications for over 1,700 generic types of medical devices and grouped them into 16 panels, or medical specialties. Example panels include Cardiovascular Devices and Radiology Devices. Each of the generic types is assigned as Class I, Class II, or Class III. RELATED POST: Complying with […]