Preparing for the FDA’s QMSR: Your Guide to Compliance Success “The only constant in life is change.” Those words, often attributed to the Greek philosopher Heraclitus, seem especially true in the medical device industry. Industry veterans have experienced a constant evolution of the regulations over the past 10 years. There was the update to ISO […]
Simplify Airborne Systems Lifecycle Milestones with Categories Gain Clarity, Reduce Risks, and Stay Compliant. Struggling to keep track of deliverables across complex aerospace projects? You’re not alone. Managing deadlines and milestones often feels like navigating a maze of documents, spreadsheets, and shifting priorities. In this webinar, you’ll discover how Jama Connect®’s Categories feature can bring […]
Empowering Complex Medical Device and Life Sciences Development with Responsible AI and Machine Learning Artificial intelligence (AI) and machine learning (ML) are transforming industries across the globe, and the medical device and life sciences sectors are no exception. Today, the development of complex medical devices is being accelerated and optimized with the integration of responsible […]
Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage The Center for Devices and Radiological Health (CDRH) is a key branch of the FDA that is responsible for ensuring the safety and effectiveness of medical devices. Companies interact with the CDRH through premarket submissions, quality inspections, recalls, and a variety […]
The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software Supports Compliance History of US Regulation The US medical device industry is governed by a complex framework of regulations designed to ensure the safety and effectiveness of products. A thorough understanding of this history provides valuable insights into the development of 21 […]
How Jama Connect® Supports Trade Compliance for Vehicle Connectivity Systems In this short demo, industry expert Fabian Koark walks through how Jama Connect helps organizations meet evolving trade compliance regulations — specifically the new 2025 update to U.S. Federal Regulation 15, targeting vehicle connectivity systems. Learn how to classify architectural elements by trade restriction, integrate […]
[Webinar Recap] Navigating AI Safety with ISO 8800: Requirements Management Best Practices As artificial intelligence (AI) becomes increasingly embedded in automotive and semiconductor applications, ensuring its safety is critical. In this webinar recap, Matt Mickle from Jama Software and Jody Nelson from SecuRESafe (SRES) dive into the newly introduced ISO/PAS 8800 provides a framework for […]
Understanding ISO 26550: Managing Variability in Systems and Software Engineering As products become more complex, companies need better ways to manage different versions and configurations. ISO 26550 helps organizations handle variability in systems and software engineering, making it easier to develop, maintain, and update product lines while ensuring quality and compliance. What is ISO 26550? […]
Overcoming Top Challenges in the Energy Storage Industry with Jama Software From aging infrastructure, to changing regulations, Jama Software® helps engineering teams meet demand with innovative, scalable solutions. This blog explores the top challenges in the industry and how Jama Software’s cutting-edge requirements management solutions can help overcome them, including: Aging infrastructure requiring urgent modernization […]
Expert Perspectives: A Conversation with the Originator of UL 4600 on Safety, Security, and Autonomy in Automotive Development Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the […]
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