Modern health care increasingly relies on electronic devices to improve quality of life and medical care. Medical devices provide life-saving capabilities: patient monitors, infusion pumps, pacemakers, and defibrillators.
The common element is, all contain significant amounts of embedded software. These devices need to behave properly and consistently, otherwise the well-being of patients is compromised.
Vector provides medical device manufacturers and suppliers with a professional and open development platform of tools, solutions and services for creating embedded systems. Vector products and services give medical engineers a key advantage in making this challenging and highly complex subject area as simple and understandable as possible.
Embedded system testing tools from Vector support you in the implementation of simulation and test environments in an efficient way. The Vector Testing Solution offers proven test tools for all test phases in medical engineering.
The development of medical embedded systems is strongly regulated, processes must comply with regulatory requirements from standards as IEC 62304 and ISO 14971. A profound documentation of the requirements and the respective system/software architecture as well as their relations are important preconditions for successful regulatory audits. To keep this complexity manageable, modelbased processes in systems engineering are on the rise.
Regardless of your task in the development process the Vector system testing tools provide a scalable and re-usable solution from pure SIL simulations to HIL testing with functional acceptance tests. No matter whether your microcontroller is part of an MRI scanner or an infusion pump.
Due to the parallel access to Networks (CAN/CANopen, Ethernet, Wifi, …) as well as by acquiring and stimulating of I/Os (analog, digital, SPI, I2C, PSI5, SENT, …) via DAQ and external hardware you can easily realize development accompanying tests. Therefore, you ensure a process conformant development of the embedded medical system functionality and network communication.
SUPPORTED TESTING ACTIVITIES
Black box testing
White box testing on host and target
Full support in the development process, from software unit test to system validation
Uniform test management, test automation (continuous integration), result analysis and traceability
Measuring of code coverage of system tests
Efficient test design by reuse of test sequences and test data (e.g. for variant handling)
Software testing is a critical part of ensuring the performance of medical devices to pass FDA audits and support the guidelines defined in IEC 62304.
VectorCAST by Vector is the solution for FDA-compliant and IEC 62304-compliant medical embedded application testing.
Qualification documents consisting of Tool Operational Requirements (TOR) and Tool Qualification Data (TQD) are available for tool validation. VectorCAST supports testing activities such as:
Unit testing and integration testing
Code coverage analysis
Continuous integration with Change-Based-Testing
Embedded target support
Automated Software Testing
Software is becoming more and more important, not only in the automotive industrie. The VectorCAST embedded software testing platform is a family of products that automates testing activities across the software development lifecycle. It supports engineers in automated and collaborative testing in application areas like aerospace, automotive, medical or railway.
Playing time 3:40 minutes, published 10/2019
Automate testing activities across the software development lifecycle.
Allows you to perform unit testing of individual functions or groups of functions to ensure that your application is meeting its requirements, without error. VectorCAST/C++ provides both pass/fail analysis as well as code coverage analysis to support the testing of any class of medical device.
Enables your engineers to assess the thoroughness of system testing by automatically recording which parts of the application are stimulated by each system test. VectorCAST/QA supports statement, branch and Modified Condition/Decision Coverage (MC/DC) coverage levels. VectorCAST/QA coverage was originally developed for the Avionics industry and now many leading medical devices companies have adopted this as a code coverage standard for their FDA Class III or IEC 62304 Class C applications.
CANoe is the comprehensive software tool for development, test and analysis of individual microcontrollers and networks of connected microcontrollers. It supports network designers, development and test engineers throughout the entire development process – from planning to system-level test.
Comfortable design of automated test sequences for embedded systems
vTESTstudio is a powerful development environment for creating automated tests. In order to increase the efficiency in terms of test design and to simplify the reusability it provides either programming-based, table-based and graphical test notations and test development methods.
To test programmable electronic medical devices thoroughly, it is not only necessary to connect the communication networks to the test system, it is also necessary to connect the I/O interfaces. This task is handled by the Vector VT System. It simplifies the setup of test benches and HIL test systems immensely, because it integrates all circuit components needed to connect an I/O channel in one module.
With Squore we offer an innovative decision-making dashboard. It enables quality management of software development by improving project performance, driving software quality and ensuring process and standard compliance.
All along the project lifecycle, the variant Squore/Software Analytics automatically collects and aggregates with its own results the measures from the various tools already in use in your environment, in order to provide an overall and historical insight on software products and processes.
SQUORE KEY INSIGHTS
Projects portfolio comparison
Software Project Quality and Performance
The better the information, the better the decisions: Squore provides smart and automated data processing enabling software teams to optimize their project management.
The development of medical embedded systems is strongly regulated. The development processes must comply with regulatory requirements from standards as IEC 62304 (software development) and ISO 14971 (risk management).
A profound documentation of the requirements (need) and the respective system/software architecture (solution) as well as their relations (traceability) are important preconditions for successful regulatory audits.
To keep this complexity manageable, model-based processes in systems engineering are on the rise. The Vector solution for this approach is an engineering environment, called PREEvision.
Model-Based Solutions for Medical Systems
An integrated approach for the E/E development process
In common with many other industries, medical technology is facing a profound upheaval. Medical devices are networked, collect data, adapt behavior and can learn independently. The days of developing a single isolated medical device are long gone – today, development focuses on medical system solutions with widely varying complexity. To keep increasing complexity manageable, model-based processes for electrical/electronic development are now available.
Originally published in “Elektronik Journal” magazine, issue “Medical Electronics” – October 2017
PREEvision is the premier engineering environment for model-based development of embedded systems that supports the entire technical development process in a single integrated application. The integrated and model-based approach helps complex tasks to remain straightforward and controllable.