Medical Engineering

Tools, Solutions and Services

Modern health care increasingly relies on electronic devices ensure a process conformant development of the embedded to improve quality of life and medical care. Medical devices medical system functionality and network communication. provide life-saving capabilities: patient monitors, infusion pumps, pacemakers, and defibrillators. The common Software testing is a critical part of ensuring the perfor- element is, all contain significant amounts of embedded mance of medical devices to pass FDA audits and support software. These devices need to behave properly and consis- the guidelines defined in IEC 62304. VectorCAST by Vector tently, otherwise the well-being of patients is compromised. is the solution for FDA-compliant and IEC 62304-compliant Vector provides medical device manufacturers and suppliers medical embedded application testing. Qualification docu- with a professional and open development platform of ments consisting of Tool Operational Requirements (TOR) tools, solutions and services for creating embedded systems. and Tool Qualification Data (TQD) are available for tool Vector products and services give medical engineers a key validation. VectorCAST supports testing activities such as: advantage in making this challenging and highly complex >>Unit testing and integration testing subject area as simple and understandable as possible. >>Code coverage analysis >>Continuous integration with Change-Based-Testing Vector Testing Solution for Embedded Systems >>Embedded target support Embedded system testing tools from Vector support you in the implementation of simulation and test environments in Supported Testing Activities an efficient way. Regardless of your task in the develop- >>Black box testing ment process the Vector testing tools provide a scalable >>White box testing on host and target and re-usable solution from pure SIL simulations to HIL >>Full support in the development process, from soft- testing with functional acceptance tests. No matter ware unit test to system validation whether your microcontroller is part of an MRI scanner or >>Uniform test management, test automation (contin- an infusion pump. Due to the parallel access to Networks uous integration), result analysis and traceability (CAN/CANopen, Ethernet, Wifi, …) as well as by acquiring >>Measuring of code coverage of system tests and stimulating of I/Os (analog, digital, SPI, I2C, PSI5, >>Efficient test design by reuse of test sequences and SENT, …) via DAQ and external hardware you can easily test data (e.g. for variant handling) realize development accompanying tests. Therefore, you

Proven tools for fast development and easy testing: Vector solutions for medical engineering. www.vector.com/medical > > VectorCAST/C++ Test Toolsfor AllTestPhases > > CANoe > > > VectorCAST/QA > > vTESTstudio > > System VT > > Squore > > > > > > > > > > > > > Vector Testing Proven Solution: test tools for all test phases inmedical engineering. Pass/fail analysis as well ascode coverage analysis Automate CandC++unit testing process, fromsystem-levelto planning test engineers Supports throughout the entire development networks of connected microcontrollers Develop, test andanalyse individualmicrocontrollers and dard for many leadingmedical device companies FDA or ClassIII code ClassC IEC 62304 coverage stan- condition/decision coverage (MC/DC) Coverage levels for branch statement, andmodified Automate system tests andcode coverage notations and test development methods Programming-based,graphicaland table-based test automatedDesign test sequences Simplifyed setup of test benchesandHIL test systems Modular test hardware for I/O interfaces Manage quality, process and standard compliance Software dashboard anddecision-making analytics

Software System Implementation Link to Requirements Software Software Unit TestUnit IntegrationTest Software System Test Software Hardware/Software IntegrationTest White-Box Testingon Target Processor Validation System White-Box Testing onHost Software System > > > > > > > > Consulting for Solutions Medical necessary changemanagement. and optimizingoping processesbusiness and performing provides ConsultingServices professional devel in support - For companies within care health the sector, Vector Vector Consulting Services > > > PREEvision based processes are insystems engineering on the rise. latory audits. To keep this complexity manageable, model- relationsare preconditions important for successful regu respectivesystem/software architecture as wellas their profound documentation of requirementsthe and the ments from standards andISO 14971. asIEC 62304 A regulated, processesmust comply with regulatory require- The development of medical embedded systems isstrongly Model-Based Systems Engineering Code Coverage Testing onHost Code Coverage > > > > > > > > > > > and Medical SPICE Process improvements with reference to CMMI Requirements andproduct engineering management Organizational changemanagement Efficiency improvement andcycle time reduction Usability according engineering to IEC 62366 inrisk managementSupport according to ISO 14971 Quality management according to ISO 13485 Software development process according to IEC 62304 backbone asengineering Can serve abstraction,Supports decomposition andreuse environmentEngineering for model-baseddevelopment System Validation on TargetDevice Fact for Sheet Solutions Medical Engineering Code Coverage CANoe VectorCAST/RSP VectorCAST/C++ VectorCAST/QA VectorCAST/QA vTESTstudio vTESTstudio VT System VT CANoe

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V1.0 | 2019-9