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2Blog Post

Introduction to ISO 24089: Your Ultimate Guide to Understanding and Implementing This New Standard for Automotive

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 […]

3Blog Post

Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements

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 […]

5Blog Post

How EN 50128 Establishes Functional Safety Standards for Railway Software

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 […]

6Blog Post

[Webinar Recap] Implementing Requirements Management for ISO 21434

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 […]

7Blog Post

[Webinar Recap] Understanding Integrated Risk Management For Medical Device

In this blog, we recap the “Understanding Integrated Risk Management for Medical Device” webinar. Companies involved in developing medical devices understand the importance of risk management, but their approaches can vary significantly in terms of the time it takes to manage risk, the ability to connect risks to specific requirements and tests, and the capacity […]

8Blog Post

[Webinar Recap] Lessons Learned for Reducing Risk in Product Development

In this blog, we will recap a webinar on reducing risk in product development Over the last 20 years, product development complexity has expanded exponentially, creating innovations in areas such as space tourism, autonomous vehicles, satellite communications, and more. In this webinar, Kemi Lewis, Senior Consultant at Jama Software, will demonstrate how Jama Connect© creates Live […]

9Blog Post

Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management

One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort.  This post gives a basic […]

10Blog Post

Why Your Medical Device Risk Management is NOT Effective

Medical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a […]