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[…] we’re looking at how we might address that. Related: How the EARS Notation Supports Effective Requirements Management and Live Traceability™ Joseph Pitarresi: So today, just as a brief example, product requirements quality drive fidelity and efficiency in the product development cycle, and if you just look at this automotive example, there’s many systems, it’s a […]
[…] Developers Project Managers Computer Scientists The standards are commonly used to guide internal work on systems development but can also be used as an external reference. For example, if you work with a partner, you might use ISO/IEC/IEEE 15288:2015 to help create agreements about how work is completed. Building a New System is Growing […]
[…] be seen how “useful” it will be. There is a huge opportunity to leverage this in ways that are beneficial for teams with the right focus. For example, we’re just starting down this path at Jama Software® with Jama Connect Advisor™, which helps train business analysts/product managers / engineers on how to write their […]
[…] which includes disposables. I’m based in Florida, but I teach and advise worldwide. Risk management is my passion. I have trained over 10,000 individuals worldwide in the latest knowledge and best practices in risk management. RELATED: Jama Connect® for Medical Device & Life Sciences Development Datasheet Elahi: The companies that have benefited from my […]
[…] a timely manner; 2) Understanding what topics the investigator may request go to next and prepare accordingly; and 3) Keeping a record of what the investigator has examined. To that end, here are roles to have during an inspection. Host – Serves as the primary interface with the investigator. This role is typically best […]
[…] tools with no need to change tools, fields, values or processes. Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments. Another core goal of CMMI Level 2 is to involve stakeholders in the requirement review and approval process (see […]
[…] difference between Verification and Validation The terms “Verification” and “Validation” often get combined and abbreviated to V&V; however, these activities are vastly different. Verification is confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. It is design-centric and answers the question “Did I build the product right?” Verification also […]
[…] It provides an accurate understanding of the implications of a proposed change, which helps the teams make informed business decisions about which proposals to approve. The analysis examines the proposed change to identify components that might have to be created, modified, or discarded and to estimate the effort associated with implementing the change. Skipping […]
Changes to requirements traceability like better visibility and collaboration will improve the efficiency of the product development process.
[…] Connect Jama Connect offers a modern alternative to document-oriented processes for medical device risk management. Jama Connect is built to help streamline compliance with ISO 14971. For example, Clause 7 of ISO 14971 requires attention to residual risks, or those risks that exist even after all risk control measures have been implemented. In Jama […]