Decoding The FDA’s Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around […]
Streamlining SOC2 Type 2 Compliance: How Jama Connect® Can Help Enable Audit Success In today’s business landscape, technology and data play a crucial role. Therefore, it is of utmost importance to prioritize the security and privacy of sensitive information. One way to do this is by undergoing a SOC2 Type 2 audit. A SOC2 audit […]
The Seven Steps to Performing FMEA Welcome to this deep dive into the world of FMEA Failure Mode and Effects Analysis (FMEA) is a powerful tool used in various industries to identify and mitigate potential failures in a process, product, or system. In this blog, we will take a detailed look at the seven steps […]
Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US regulation on quality […]
An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions. Ensuring the safety and effectiveness […]
Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software® During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards. Key takeaways from this webinar: Learn about available […]
UK regulators name 3 approved bodies to ease device certification bottleneck A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.” Dive Brief: The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K. As a result of Brexit, […]
Streamline your systems engineering efforts and ensure your products meet all the necessary industry standards. Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing space systems development. It can optimize your systems engineering efforts and ensure your products meet all the necessary industry standards. Learn how to incorporate regulations governing […]
MIL-STD-810: Ensuring Quality and Reliability in Challenging Defense Environments From the desert to swamps to the frozen tundra, the United States Department of Defense (DoD) created the Military Standard 810 (MIL-STD-810) to enforce manufacturers deliver a product that will not fail in operational environments. This compliance regulation outlines environmental engineering considerations for testing equipment’s durability, […]
Unveiling the NASA Systems Engineering Handbook Rev2: A Comprehensive Guide for Space Exploration NASA, the National Aeronautics and Space Administration, has been at the international forefront of space exploration for decades, pushing the boundaries of human knowledge and expanding our understanding of the universe. Behind every successful NASA mission lies a robust framework of engineering […]
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