Renesas Synergy™ 平台安全解决方案 - IEC 62304 C级预认证

Medical device manufacturers are required by regulatory bodies, to responsibly assess the adequacy of off-the-shelf software developer’s activities and undertake additional efforts needed to ensure that the software is validated for the manufacturer’s intended use. By preparing the IEC 62304 Class C Pre-Certified Renesas Synergy™ Platform Safety Solution, Renesas delivers the assurance of a quality driven software development process for the software package supporting the underlying high-quality microcontroller hardware; thereby enabling quicker assessment and integration of the platform for use in a medical device. The medical device manufacturer can use the information being made available through this solution, as a starting point for their required validation and market approval processes.

Accelerate Medical Device Development

While the medical device industry recognizes the benefits of commercial off-the-shelf products for software and hardware, they are rightfully mandated to maintain rigor and implement risk control measures prior to incorporation of the same towards a medical application. As a result, when a software is not internally developed, medical device companies have to allocate significant design resources for validating whether the acquired software meets expected quality as dictated by standards. To support customers facing this issue, Renesas has developed an industry-leading IEC 62304 Class C pre-certified safety solution using the Renesas Synergy™ Platform. To help accelerate the activity of programmable electrical sub-system design, the Renesas Synergy™ Software Package (SSP) integrates all the functionality needed to build IoT applications including Express Logic’s ThreadX RTOS and X-Ware middleware, application frameworks, functional libraries, HAL drivers, and board support packages for the Synergy kits.

To further demonstrate dedication to support the validation activity required by standards applicable to the medical industry, Renesas maintains and offers delivery of comprehensive documentation attesting to the quality of the software and testing process in place, which are reviewed by globally respected inspection and certification bodies. Through mapping of organizational processes used for development of the SSP to guidelines provided by IEC 62304, device manufacturers can assess the adequacy of the components in the SSP for use in their product and apply additional measures, if necessary, to close any gaps for validation.

Solution Highlights

  • Integrated hardware and software platform
  • Improves time to market, total cost of ownership, and the regulatory certification burden
  • Synergy Software Package (SSP) components certified to IEC 62304 Class C
  • Express Logic X-Ware IoT Platform™, and IAR tool chain certified to IEC 62304 Class C
  • Safety claims backed by evidence and documentation
  • SSP is fully supported same as the software product
  • Application support provided

Renesas Safety Solution Claims & Supporting Arguments

Renesas uses an IEC 62304 compliant SDLC flow for the Synergy product line

  • Based on ISO/IEC/IEEE 12207 SDLC process
  • Developed with premium software quality assurance (SQA) tools
  • Validated and verified to best practices, which are audited and continuously improved
  • Regular periodic maintenance releases
  • Defined processes for development phases and transitions between each phase
  • Established common framework for software lifecycle process

Renesas can support your ISO 13485 purchasing controls for the Synergy product line

  • Maintain comprehensive product documentation and specifications
  • Maintain organizational accreditations for quality management systems (QMS)
  • Maintain stringent downstream purchasing controls

Synergy Platform provides mechanisms to protect the integrity and confidentiality of critical data at rest

  • Error detection and correction (DED), and parity checking in SRAM
  • HW accelerated CRC to augment error detection
  • Stuck-bit detection using high-speed RAM march tests (DOC)
  • Early warning of brown-outs or power-supply glitches (LVD)
  • Battery-backed regs. for critical data storage (Battery Backup Fn.)
  • Fixed-key protection for special function registers

 

Synergy Platform provides mechanisms to enable self-checks for potentially critical hardware functions

  • Hardware self-diagnosis functions on ADC (ADC self diagnosis)
  • Clock accuracy reporting (CAC)
  • Independent readback of port pin status (GPIO readback level detection)
  • Bounds checking at application level (Thread Monitor F/W with WDT/IWDT)
  • Error detection and correction (ECC), and parity checking in SRAM
  • Certified self-test library options (IEC 60730 Class B and IEC 61508)

Synergy Platform provides "fail-safe" or "fail-secure" mechanisms

  • Known system state reversion with exception handling (NMI, MOSC Stop Detect)
  • Independent monitoring of system operation (IWDT)
  • Detect and capture failure events with RTC (RTCIC)
  • High-Z fail-safe for PWM pins (POEG)
  • Documented cause of reset (Reset SFR)

Synergy Platform provides "fail-operational" mechanisms

  • Partial system operation as fallback (CGC, MOSC Stop Detect)
  • Known system-state reversion with exception handling (NMI, MOSC Stop Detect)
  • Independent RTC operation for accurate timestamps (RTC, XCIN sub-osc)
  • Battery-backed regs. for critical data storage (Battery Backup Fn.)
Solution Contents
Documentation Publicly Available Documentation In-Package Documentation on Request/Auditable
MCU HW Datasheets Index of Documents SW Req. Traceability Matrix^
SW Datasheets TUV IEC 62304 Class C Certificate SW Requirements Document ^
SW Module Guide Bundle Report on the Certificate SW Design Description ^
SW Quality Summary Report Technical report of the Type testing SW Verification Results ^
SW Accomplishment Summary Software Safety Manual FMEA Documentation ^
SW Quality Handbook Software Development Plan SW Delivery Mechanism
Semiconductor Reliability Handbook Software Configuration Management Plan SW Release & Maintenance Process
  Software Development Lifecycle Purchasing Controls
  Software Coding Standard Requirements Based Testing (Developer Unit, Functional, Integration, Regression) ^
  Software Quality Assurance Plan  
  Software Verification Plan  
  SW Performance Benchmark & Metrics Reports  
  Problem Reporting Procedure  
  Express Logic X-Ware Components Certification Pack (From Express Logic)*  
  IAR Tool Chain Certification Pack (From IAR) *  

* Available through Renesas for Key Customer Engagement
^ Available for each certified module

NDA required documentation can be downloaded from Synergy Gallery with approval from Renesas. Contact your local sales team for further details. *Express Logic X-ware components and IAR tool chain IEC 62304 licenses can be made available at preferred rates through Renesas.

 

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