Medical
Engineering

Agile and holistic systems engineering with PREEvision: Create and manage digital models of complex systems with a comprehensive set of Model-Based Systems Engineering (MBSE) tools and full support for the RFLP approach (Description of Requirements, Functions, Logical, Physical in the context of System Design).

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Medical device manufacturers need high-quality software development to meet stringent standards like ISO 14971, ISO 13485, IEC 62304, IEC 60601,Medical SPICE, and FDA regulations. Vector Consulting Services provides professional support in product development and agile process transformation, code quality analysis and security tests for robust cybersecurity.

You can efficiently plan, manage, simulate, test and commission CANopen networks with our CANopen option for Vector CANoe. During the system design phase, you can simulate the future behavior of a system, estimate the bus load, and draw conclusions such as the required hardware performance.

During system validation, the medical device must be tested in an environment where it cannot tell the difference between the real environment and the test environment. For this purpose, the I/O’s of the medical device are connected to a Vector VT System, or Vector VIO System, which allows easy setup of test benches.

Looking for a state-of-the-art test environment for system validation of medical devices? Vector CANoe offers many open interfaces and make it very easy to adapt to your test environment. Simply test the integration of hardware, check digital and analog I/Os with Vector VT System, or connect to external test systems via program and scripts calls, or just use tools like IBM DOORS for traceability, requirements, and much more.

Service-Oriented Device Connectivity (SDC) is a protocol for standardized data transfer between connected medical devices. For the development of medical devices, we offer efficient simulation and test environments that can be used in all phases of product development. And our IEEE 11073 SDC Stack and Integration Kit offers medical device manufacturers an efficient way of integrating the standard into their devices.

Complying with IEC 62304 is essential for ensuring the safety and efficacy of medical devices. With VectorCAST, developers can ensure that their software meets the stringent requirements of IEC 62304. Thorough testing procedures allow manufacturers to identify and rectify any potential issues or vulnerabilities, ensuring that their devices meet the FDA's standards for safety and effectiveness.

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Automate your unit testing for C and C++: VectorCAST/C++ allows you to perform unit tests on individual functions or groups of functions to ensure that your application meets its requirements without errors. The tool provides both pass/fail analysis and code coverage analysis to support the testing of any class of medical device.

The use of artificial intelligence in a regulated environment such as medical technology is associated with numerous challenges. AI is very different from traditional rule-based algorithms and therefore requires new methods for validating AI. One of the most important requirements for AI is explainability and transparency.