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A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss Lockheed loses contract award protest in part due to insufficient Modular Open Systems Approach (MOSA) documentation. On April 6th the GAO handed down a denial to Sikorsky-Boeing proposal protest of the Army tiltrotor award to Textron Bell team. This program is called […]
What is a Trial Master File in the Medical Device Industry? A Trial Master File, also known as a TMF, is a collection of records and documentation about the creation, evaluation, and regulatory approval of a medical device. It shows the quality control procedures used in the device’s design, production, and testing to make sure […]
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 […]
Streamlining Defense Contract Bid Document Deliverables with Jama Connect® In the defense sector, whether it is a large prime, a subcontractor, or one of the thousands of other organizations under the defense umbrella, winning a contract bid for the United States Government comes with as astronomical amount of document deliverables that can be daunting and […]
Jama Connect® Features in Five: Using Jama Connect with a Quality Management System (QMS) for Medical Device & Life Sciences Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect®’s powerful features… in under five minutes. […]
The Top Challenges in Industrial Manufacturing and Consumer Electronic Development From supply chain disruptions to digitization – learn more about what development teams are up against and get expert suggestions for how to overcome them PART I: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development Industrial manufacturing has always been a cornerstone of […]
Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part 2 In our previous blog post, we reviewed the top things to know about software validation and computer software assurance in the medical device industry. In this installment, we’ll take a closer look at computer software validation and […]
Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety Have you heard of FuSA? It stands for Functional Safety, and it is a vital part of any system that requires safety assurance. FuSA was designed to reduce the risk of physical injury or damage due to malfunctioning equipment. […]
Revolutionize Your Software Development Process with Seamless Integration of Jama Connect and Atlassian Jira Nearly all of Jama Software®’s clients engage in software development to some degree. In some cases, the products they build are entirely software-based, and in others, software is just one critical component of a more complex system. Because most software engineering […]
Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I Intro This is Part 1 of a 2-part series on software validation and computer software assurance in the medical device industry. While it is clear that software validation is required by regulation in the US and elsewhere […]