Archive for category: Compliance & Regulation

Category: Compliance & Regulation

Empowering Complex Medical Device and Life Sciences Development with Responsible AI and Machine Learning

June 20, 2025 in /by

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

June 12, 2025 in /by

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

May 29, 2025 in /by

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

May 8, 2025 in /by

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

April 8, 2025 in /by

[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

March 25, 2025 in /by

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

March 6, 2025 in /by

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

March 4, 2025 in /by

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 […]

[Webinar Recap] Accelerate Your ECSS Standards Compliance with Jama Connect®

February 27, 2025 in /by

Ensure your space systems meet industry standards with ease. The European Cooperation for Space Standardization (ECSS) provides a unified set of standards to streamline space system development and promote interoperability among international agencies. Our customers are leveraging Jama Connect® to comply with ECSS standards, resulting in enhanced collaboration, reduced risk, and mission success in the […]

Understanding ISO 26580: The Standard for Agile Product Line Engineering

February 25, 2025 in /by

Understanding ISO 26580: The Standard for Agile Product Line Engineering Modern organizations face the challenge of balancing speed, compliance, and innovation, particularly when managing complex systems across multiple product lines. ISO 26580 provides a structured approach to addressing these challenges by standardizing Agile Product Line Engineering (APLE). But what exactly is ISO 26580, and why […]