IDE for medical device software development Hyun-Do Lee, Field Application Engineer
Agenda SW Validation Functional safety certified tool IAR Embedded Workbench Code Analysis tools
SW Validation
Certifications of Medical device
IEC 62304 Medical device software life cycle process Replace ANSI / AAMI / SW 68: 2001 Based on ISO 12207 -Software life cycle processes Provides the framework of life cycle needed for safe development and maintenance of medical device software IEC / ISO joint development
IEC 62304 Medical device management standards ISO 14971 ISO 13485 Lay out a foundation to develop a medical device affects affects Medical device product standards IEC 60601-1 IEC 61010-1 requires Medical device process standards IEC 62304 affects Implementation of medical device software Gives specific direction for evaluation of a safe medical device Gives detailed direction how to develop and maintain safe software system Other source of information IEC/ISO 12207 IEC 61508-3 IEC/ISO 90003, inspires Gives additional guidelines, techniques, etc that may be used
SW Validation Over view of software development processes and activities, IEC 62304
V-Model Embedded Trust - Security IAR Visual State IAR Embedded Workbench C-STAT, C-RUN I-jet, I-jet Trace Systematic Software testing Rick D. Craig and Stefan P. Jaskiel
Development and testing 1. C is not safe data type conversion, pointer accesses etc. 2. All software contains bugs 3. The later you find a bug, the more expensive it gets Cost $ System test $$$ Development cycle $$$$$$ product recall
Functional safety certified tool
Functional safety and reliability One of the most important features in many embedded systems today, especially within automotive, industrial automation and medical Coding standards Safety requirements Proof of compliance for tools
Solutions for safety-critical applications Certified toolchain A special functional safety edition of IAR Embedded Workbench Simplified validation Functional Safety certificate from TÜ V SÜ D Safety report from TÜ V SÜ D Safety guide Guaranteed support through the product life cycle Prioritized support Validated service packs Regular reports of known problems Available for: ARM Renesas RX Renesas RL78 Renesas RH850 Validated according to: IEC 61508 ISO 26262 EN 50128 (ARM) IEC 62304 (RX, ARM)
Simplified validation Functional safety certificate from TÜ V SÜ D Safety report from TÜ V SÜ D Safety Guide Complement to the IAR Embedded Workbench user guides Highlights issues to be considered when using the build toolchain for projects with functional-safety requirements Includes system considerations, implementation and coding considerations, etc.
Validated product versions Validated service packs Validated service packs Non-validated feature releases x.xx.x Validated version: IAR Embedded Workbench for EWXXXFS x.xx.x Validated version y.yy For a certified product, a new certified version is released approximately every 12-18 months A certified version is considered a frozen version, on which bug fixes are applied in terms of validated service packs No new product features are added to a certified version or the corresponding service packs
IAR Embedded Workbench
Integrated analysis tools Code analysis prioritized customer request Runtime analysis C-RUN launched in 2014 Static analysis C-STAT launched in 2015 Fully integrated runtime and static analysis Maximized performance by compiler experts IDE tools Editor Project manager Library tools Build tools IAR C/C++ Compiler Assembler Linker C-SPY Debugger Simulator driver Hardware debugging Power debugging RTOS plugins We enable developers to take full control of their development and gain efficient, adaptable workflows delivering dependable products.
Quick start Thousands of example projects Getting started guides and tutorials Templates and quick access to RTOS integration Direct links to technical support, release notes and product updates through My Pages
User-friendly IDE Smart Source Browser Feature-rich editor Clean, robust, and fast user interface Powerful Project Manager Arrange multiple projects within the same workspace Find and list all references for a symbol
User-friendly IDE Intuitive menu system Multiple views and dockable windows Integrates with commonly used version control systems Set breakpoints while editing the code before starting the debugger Comprehensive documentation Context-sensitive online help with library function lookup
Powerful C/C++ compiler Multi-file compilation allows the optimizer to operate on a larger set of code The linker can remove unused code Option to maximize speed with no size constraints Multiple levels of optimizations for code size and execution speed Major functions of the optimizer can be controlled individually Balance between size and speed by setting different optimizations for different parts of the code Well-tested Commercial test suites Plum-Hall Perennial Dinkumware library test In-house developed test suite >500,000 lines of C/C++ test code run multiple times Processor modes Memory models Optimization levels Language standards ISO/IEC 9899:1990 (C94/C90/C89/ANSI C) ISO/IEC 9899:1999 (C99/Standard C) ISO/IEC 1488:2003 (Standard C++) Embedded C++ and Extended Embedded C++ dialects
Comprehensive debugger Integrated debugger for source and disassembly debugging Timeline window RTOS awareness Dockable windows and tab groups Edit source files without leaving the debug session Power vizualization Performance analysis
Comprehensive debugger Broad range of supported in-circuit debugging probes C-like macro system to extend debugger capabilities Trace support Direct flash erase and download Built-in simulator driver
Integrated profiling tools Function profiling Based on simulator, sampled trace or full trace Execution time per function Select time interval Timeline window shows the application s profile Interrupt log, Data log, Event log, Call stack Code coverage analysis Which code has been executed? Stack analysis calculates maximum stack usage, helps find the optimal stack size, and checks stack integrity at runtime to detect overflow
Power debugging Tune the application to minimize power-consuming use of hardware resources Enabled by I-jet or other hardware with power debugging support Integrated measuring of power consumption correlated to the source code Function-level power profiling Power breakpoints Detailed power logs 24
Code Analysis tools
C-STAT static analysis Fully integrated in IAR Embedded Workbench Intuitive and easy-to-use settings with flexible rule selection Extensive and detailed documentation Checks compliance with MISRA C:2012, MISRA C++:2008, and MISRA C:2004 Includes ~250 checks mapping to hundreds of issues covered by CWE and CERT C/C++
C-RUN runtime analysis Fully integrated in IAR Embedded Workbench for Arm and RX Bounds checking Arithmetic checking Heap and memory leaks checking Intuitive and easy-to-use settings with flexible rule selection Code correlation and graphical feedback in editor Comprehensive and detailed feedback Very efficient instrumentation of compiled code
Take full control of your development Implement your design in code Build and debug the application Let C-STAT analyze your code Let C-RUN analyze your project Review potential issues Investigate runtime errors Requirements Design Implementation Verification Maintenance
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