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Applications of Systems Engineering in Healthcare When it comes to healthcare, time to market is one of the most crucial aspects of success or failure. However, medical product development teams face several challenges that slow product development, and in the quest to speed up the process, some teams are turning to systems engineering to improve […]
Pioneering Excellence in Healthcare: Q&A with Systems Engineering in Healthcare On December 5th, 2023, Jama Software® hosted an exclusive one-day thought leadership event, featuring industry experts Chris Unger – Retired GE Healthcare Chief Systems Engineering Officer – PracticalSE LLC, Bijan Elahi – Founder of MedTech Safety, and Vincent Balgos – Director of Medical Device Solutions […]
What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security A comprehensive guide to understanding ANSI/AAMI SW96:2023 and mitigating security risks Introduction Managing risk around a medical device’s entire lifecycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need […]
A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn In the realm of business, the economy is a dynamic force that ebbs and flows, much like the tide. Economic downturns, while challenging and sometimes scary, can also present unique opportunities for businesses to reevaluate their strategies, streamline their operations, and invest wisely […]
Embracing security as an important part of the product development cycle provides more than just a competitive advantage – it may be crucial for survival.
ISO 24089, developed by the International Organization for Standardization (ISO), is a standard that provides guidelines for managing software updates in a methodical and orderly way. Planning, testing, deployment, and monitoring are all included in the framework for managing the software update process that is specified by the standard. The main requirements and advantages of […]
Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements Executive Summary One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
How EN 50128 Establishes Functional Safety Standards for Railway Software In increasingly complex, rapidly evolving, and highly regulated industries, product development teams must build safety-critical products, while streamlining risk management and keeping accuracy and security at the forefront. This blog post will define functional safety and EN 50128 and explain why compliance with safety standards […]
In this blog, we recap the “Implementing Requirements Management for ISO 21434” webinar. As the automotive industry becomes more complex and more connected, cybersecurity is emerging as a major concern, and therefore priority, for development teams. According to Juniper Research, there are 206 million cars on the road with embedded connectivity and by 2025, the […]