Solutions for Medical Engineering

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/C++ 

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.

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.

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
• Integrated traceability
• 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

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.