An avionics team three months into a DO-178C (Software Considerations in Airborne Systems and Equipment Certification) effort discovers that many of their high-level requirements have no linked test cases. They had been running test cycles for weeks against requirements that were never fully verified or traced. The rework pushes certification timelines back and adds weeks […]
A flight control algorithm passes every simulation on a desktop workstation. The math checks out, the logic is sound, and the team moves to integration. Then, running on the actual electronic control unit (ECU) with real analog signals and millisecond timing constraints, the controller drops samples during a fast transient and clips an internal variable. […]
A defense program contracts three suppliers before holding its Preliminary Design Review (PDR). Six months into development, each supplier has interpreted the system requirements differently because no authoritative baseline existed when contracts were signed. The integration milestone becomes a discovery event, revealing interface conflicts that trace back to requirements the teams never reconciled. This retroactive […]
Engineering Governance is a Critical Business Strategy for Product, Project, and System Development Excellence Having a robust business strategy that reduces risk is critical for managing complex product, project, and system development. What Is Engineering Governance? Engineering governance is a system of policies, processes, and standards that guides everything from product or project design to […]
IEC 62304 Edition 2: What to Expect and Why It Matters IEC 62304, the international standard governing medical device software lifecycle processes, is undergoing its first major revision in nearly 20 years. While the upcoming second edition aims to clarify requirements and better reflect modern software practices, it also intentionally preserves the stability manufacturers rely […]
The Simplification of the EU MDR: What MedTech Needs to Know The European Medical Device Regulation (EU MDR) continues to present challenges for quality and regulatory teams, as well as for the medical device industry more broadly, years after its publication. The updated legislation was introduced with the objective to improve patient safety and harmonize […]
Jama Connect Features in Five: Automotive Solution In this Features in Five session, Grant Rhodes, Senior Solutions Consultant at Jama Software, explores how Jama Connect’s Automotive Solution empowers teams to streamline compliance and accelerate development in the automotive industry. Key highlights include: Purpose-built support for automotive systems and components, ensuring compliance with ISO 26262, […]
What is ISO 13485? A Simple Guide for Medical Device Professionals Introduction If you’re a medical device professional, you’ve very likely heard of ISO 13485. But reading the standard can feel like diving into a boring, theoretical document that seems designed to slow you down. You have products to develop and deadlines to meet. You […]
Jama Connect® Supports Export-Restricted and ITAR Use Cases Organizations operating under export restriction and/or International Traffic in Arms Regulations (ITAR) face unique challenges when selecting collaboration tools for product development. These regulations, designed to control the export of defense-related articles and services, require stringent data handling and access controls that many standard software platforms cannot […]
Write Clear Design Inputs: A Practical Guide to ISO 13485 Compliance In the medical device industry, the clarity of your design and development inputs is vital. Unclear or conflicting requirements can slow down development and make it harder to meet regulatory expectations. This session offers practical guidance to help ensure your design inputs are clear, […]
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