The growing usage of embedded software in medical devices as well as their growing connectivity are two of the main drivers for innovation in medical engineering.
At the same time this leads to an increasing complexity and additional regulatory requirements (e.g. from FDA and IEC 62304) in the development of electronic devices that medical device manufacturers are facing.
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.
Vector provides medical device OEMs, CMOs and suppliers with a professional and open development platform of tools, software components and services for creating embedded systems. Three fields of application are in particular focus:
Software Testing Automating FDA and IEC 62304-compliant testing activities across the software development lifecycle of programmable electronic medical systems.
System Testing Realizing development accompanying SIL simulations and HIL tests with parallel access to bus systems (e.g. CAN/CANopen and IP/Ethernet) and I/Os (analogue and digital).
Systems Engineering Model-based design, management and documentation of programmable electronic medical systems.
Automated Tests of Embedded Medical Applications
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 complete FDA-compliant and IEC 62304-compliant medical embedded application testing. Respective 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
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.
Achieve FDA compliance for medical devices within tight deadlines: A case study presentation by Hossam Yahia (Brightskies Technologies) at the Vector Testing Symposium 2018.
Achieving FDA Compliance within Tight Deadlines
A case study
Presentation by Hossam Yahia (Brightskies Technologies) during the Vector Testing Symposium 2018, Stuttgart (Germany).
Playing time 18:53 minutes, published 7/2018
Simulation and Test Environments for Medical Systems
Embedded system testing tools from Vector support you in the implementation of simulation and test environments in an efficient way. Regardless of your task in the development process the Vector 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.
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.
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.
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.
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.
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. PREEvision supports the tried-and-tested system engineering principles of abstraction, decomposition and reuse and can serve as engineering backbone: it enables parallel work on a common database from multiple locations. It provides several advantages for the development of medical embedded systems:
Early evaluation of system architectures
Design, management and documentation of complete medical electronic systems in one tool
Graphical modeling in diagrams
Design of safety-relevant systems with integrated support of e.g. HAZOP, FMEA, FTA
Efficiency through concepts such as reuse and product line/variant management
Complete development from stakeholder requirements to software/hardware architecture based on one source
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.