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, […]
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 […]
Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know As a product development team working in the medical device sector, assuring the dependability and safety of your products is crucial. FMEDA, or failure modes, effects, and diagnostic analysis, is a method frequently used to assess potential failure modes and […]
European Cooperation for Space Standardization (ECSS) Standards and Engineering Guidance The exploration of space and the development of technology have long been at the forefront of human ambition and ingenuity. As organizations in the European space sector strive to build new space systems, cooperation and standardization become vital components for success. The European Cooperation for […]
ARP4754A / ED-79A: Enhancing Safety in Aviation Development Safety is always put first in the aviation sector. Strict adherence to rules and demanding standards helps to preserve this commitment to safety. This is where ARP4754A, a significant standard, comes into play. In this blog post, we will discuss the importance and function of ARP4754A (and […]
What Are DO-178C and ED-12C? Safety is the top priority in the aviation industry. Whether it’s a civilian plane, a military jet, or an uncrewed aerial vehicle, the reliability and integrity of onboard software are essential to guaranteeing safe and secure operations. This blog will look at the importance of DO-178C (and its EASA equivalent […]
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