Vector Medical Engineering Symposium 2025

From Cars to Care: Ensuring Regulatory Compliance Using Automotive Tools in Medical Device Development – a Show Case

The advantages of automotive development tools can be leveraged for the development of medical devices — provided they meet regulatory requirements such as IEC 62304, ISO 13485, MDR, and FDA 21CFR.In this presentation, you will gain insights from a practical example demonstrating how automotive-certified development tools (e.g., code generators, test and configuration tools) can be applied in medical device development in a traceable, auditable, and compliant manner. The target audience includes medical device manufacturers seeking to adopt proven automotive tools with full regulatory assurance, as well as manufacturers from the automotive sector looking to enter the MedTech market. Participants will learn how to systematically apply regulatory requirements to development tools, what typical challenges may arise, and how a practical toolkit for demonstrating compliance can be structured.

Tackling R&D Challenges in the Development of interoperable “Medical Things”

The future of acute care relies on interoperable medical devices within an Internet of Medical Things (IoMT). This transformation faces challenges in standardization, regulatory compliance, and development processes. This talk provides an overview of key obstacles in IoMT development and offers practical strategies to overcome them.

Compliance by Design: Booster for the Development and Approval of Medical Devices

Innovative strength is the strongest growth driver in the medical technology industry. With increasing price and competitive pressure, the innovative strength and time-to-market of the R&D/RA/CA teams determine the effectiveness of the marketing and sales teams.

Introduction to the Robot Assisted Surgery (RAS) Market

The rapidly rising number of cyberattacks in the medical sector demonstrates the obvious demand for cyber resilience in the development of medical devices. Regulatory requirements, e.g., FDA, thus demand cybersecurity engineering methods like security by design and cybersecurity testing. In this presentation, we will show how an extended Grey Box Penetration Test (GBPT) effectively and efficiently identifies vulnerabilities and produces fewer false positives. Practical examples from critical industries round off the presentation.

Automated Testing of Surgical Robots: Using Vector Tools. A Scalable Solution.

Distalmotion’s presentation will focus on the automation process for validating its Dexter surgical robot using Vector tools across the full V-cycle. The session will highlight the use of CANoe, vTESTstudio, and VT System for software and system testing through HIL setups. We will also demonstrate how CANoe, as an open platform, enables seamless integration with external tools for advanced testing.

Testing of Complex Lab Automation Solutions at Siemens Healthineers

The Atellica Solution integrates immunoassay and clinical chemistry analysis, processing hundreds of samples per hour. Its modular architecture requires a test system, which must reflect the current state of development, ensure backward compatibility and replicate the physical behavior of mechanical components. The talk shares insights on how CANoe can be used to realize such a test system.

Enhancing Medical Device Software Quality Through Coding Standards and Static Analysis

Discover how consistent coding standards and static analysis can significantly improve software quality in medical device development. This talk explores practical strategies to meet IEC 62304 requirements, reduce defects early, and ensure maintainable, compliant code — using tools like MISRA, CWE, and static analysis.

Accelerating SDC Integration: Simulation and Testing for Rapid Development

Service-oriented Device Connectivity (SDC) offers a powerful framework for interoperable medical device networks, but its complexity often poses a barrier to rapid prototyping and testing. This talk presents a practical approach to overcoming these challenges through simulation, traffic analysis, and automated testing using CANoe — a toolset that supports embedded device development in both Software-in-the-Loop (SiL) and Hardware-in-the-Loop (HiL) scenarios.  

Trust That Counts: 100 Million Systems for Your Health

Many manufacturers of safety-critical systems rely on the tools and embedded software developed by Vector. Over the last 30 years, both have proven themselves in over 100 million systems through the stability and trust of our existing customers. It is precisely these virtues, together with a simple and developer-friendly development tool and configuration management, that we now want to make available to other markets such as medical device development.

Efficient Grey-Box Penetration Testing for Medical Devices

The rapidly rising number of cyberattacks in the medical sector demonstrates the obvious demand for cyber resilience in the development of medical devices. Regulatory requirements, e.g., FDA, thus demand cybersecurity engineering methods like security by design and cybersecurity testing. In this presentation, we will show how an extended Grey Box Penetration Test (GBPT) effectively and efficiently identifies vulnerabilities and produces fewer false positives. Practical examples from critical industries round off the presentation.