Compliance & Regulation

  • Agile SPICE: What It Is and How Jama Connect® Enables Compliance 

    Your team has been running Agile for years. Stories are planned in Jira, sprints run on two-week cycles, and the sprint board tells you exactly where everything stands. Releases ship on time, retrospectives close out action items, and the Definition of Done is defined and followed.  Then comes the requirement: Automotive SPICE® (ASPICE) compliance.  When your…

  • Vibe Coding vs Spec-Driven Development: What Are the Differences?

    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…

  • What Is Hardware-in-the-Loop (HIL) Testing, and When Do You Need It?

    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.…

  • ISO/IEC/IEEE 15288: A Guide to the Systems Engineering Lifecycle

    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 production. It serves as the guiding star for engineering teams to ensure that they…

  • [Webinar Recap] 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 on for compliance. This webinar, co-presented with Medical Device HQ, provides…

  • 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 regulatory standards across EU Member States. Four years after the initial…

  • Jama Connect® Features in Five: Automotive Solution

      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: With Jama Connect, automotive teams can reduce rework, prevent recalls, and bring…

  • 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 need a straightforward explanation of what it is, why it matters,…

  • 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 accommodate. Jama Connect provides a robust foundation for…