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Solutions for Medical Engineering
In medical technology, electronics improve medical care and help save lives. Whether patient monitors, infusion pumps, pacemakers or defibrillators: modern devices can no longer do without embedded software.
Nevertheless, they must behave correctly and consistently, all the more so when they are networked together. This makes their development process more complex and leads to additional regulatory requirements through standards such as IEC 62304 or FDA.
Ward Rounds With Vector | Medical Engineering Solutions
Accelerated development and simplified testing of medical electronics: In compact "Ward Rounds with Vector" online sessions, we present development and testing solutions for software-based systems in medical engineering.
Embedded Systems Engineering for Medical Electronics
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.
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Are you interested in engineering solutions for electronic and software in medical and healthcare applications? Then let's talk!
Helping to simplify the development of electronics and software.
Areas of Application
Vector Testing Solution for Embedded Systems
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.
Develop Applications Faster and More Flexible
Finding and validating the right software parameters for an embedded system is a time-consuming, iterative process. Established standards can help to accelerate the development enormously.
Software Analytics for Software Project Quality and Performance
The better the information, the better the decisions: Improve project performance, drive software quality and ensure process and standard compliance with decision-making dashboards.
Vector Consulting Services
For companies within the health care sector, Vector Consulting Services provides professional support in developing and optimizing business processes and performing necessary change management.
Model-Based Systems 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.
Vector Testing Solution for Embedded Systems
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)
CASE STUDY HIGHLIGHT
Rotaflow II Extracorporeal Life Support System
Testing the software of a new ECLS controller board including simulating and stimulating of the surrounding external systems.
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 Unit Testing and Code Coverage Measurement
VectorCAST accelerates the verification of software with unit tests and code coverage metrics. It optimizes the test process through automation, parallel test execution, and change-based testing, and can seamlessly be integrated into a CI workflow.
Automation for C and C++ unit testing
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.
System test automation and code coverage
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.
TEST TOOLS FOR ALL PHASES
Vector Testing Solution
Proven test tools for all test phases in medical engineering
Our embedded system testing tools support you in the implementation of simulation and test environments in an efficient way.
Testing medical systems and networks
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.
Modular test hardware
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.
Speed Up the Process With XCP
Besides code generation, parameterizing the application to a specific embedded system is an extensive task.
Parameters are changed, for example, to set the system to a certain state, to simulate a switching state or to change the behavior of a controller.
In a typical development process, it is necessary to make the changes in the code.
In order for the changes to become active in the embedded system, compilation and flashing must be done with each change.
This is different in a development process with the standard protocol XCP:
Faster and More Flexible With the Universal XCP Protocol
The "eXtended Calibration Protocol" allows read and write access to the memory of the embedded system.
Any number of parameters can be changed at runtime. The parameters are no longer changed in the code with subsequent compiling and flashing, but simply and quickly via the user interface.
To check the system, the measurement data is recorded directly via XCP. The acquisition of the measurement data is triggered by events in the embedded system (e.g. end of a time slot).
The data are always related to each other in time. Which data is measured is not specified in the code. It is done through the configuration of the measurement and parameterization tool. The embedded system becomes a white box.
XCP is designed as a master-slave solution. The XCP driver runs in the embedded system as access to the system's memory. CANape is the XCP master and the universal tool for parameterization and measurement. It is also used to manage parameter sets of any size and to evaluate the measurement data.
The options for evaluating measurement data range from visualizing the data to using mathematical functions to automated data analysis with report generation.
Universal Platform for Measurement and Parameterization
CANape is a universal measurement tool for recording different values. For example, physical variables such as pressure and temperature and internal variables from embedded systems. It is also optimized for parameterizing embedded systems. While the measurement is running, you can change parameters and observe and record the effects. Communication between CANape and the embedded systems takes place via protocols such as XCP.
Manage Quality, Process and Standard Compliance
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
- Overall rating
- Trend analysis
- 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.
Vector Consulting Solutions for Medical
Rising quality awareness as well as increasing cost pressure in the public health sector create high demands on hospitals, pharmaceutical companies, and manufacturers of medical equipment. At the same time, vulnerabilities in modern electronic devices dramatically increase with complexity and connectivity.
For medical companies, Vector Consulting Services provides professional support in developing and optimizing business and engineering processes. As part of the Vector Group, we work with the industry to improve efficiency with reference to Medical ASPICE, to manage quality according to standards and to minimize risks and increase safety.
Through necessary change management, our consultants achieve cost efficiency with measurable benefits, thanks to our experiences in implementing lean and agile processes.
MEDICAL CONSULTING SOLUTIONS
- Software development process according to IEC 62304
- Quality management according to ISO 13485
- Support in risk management according to ISO 14971
- Usability engineering according to IEC 62366
- Efficiency improvement and cycle time reduction
- Organizational change management
- Requirements engineering and product management
- Process improvements with reference to CMMI and Medical SPICE
Vector Consulting Services
Solutions for medical
Our consultants achieve cost efficiency with measurable benefits due to our experiences with implementing lean and safe business processes and with supplier management.
Manage Complexity with Model-Based Processes
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
The model-based engineering solution
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.