Medical Validation Suites for
Weston Embedded
Solutions' Cesium RTOS Device Certification
Demonstrating compliance to FDA 510(k), IEC 62304
Delivered 100% complete, Validated Software’s Cs/OS2 Medical Validation Suites are ready to submit for FDA or IEC certification. Medical Validation Suites contain everything needed to demonstrate the level of confidence required for certification at any Safety Class Level. Each package contains complete designs, source code, test code, test results, trace matrices and all related documentation for certification up through Class C.
VSC’s Medical Validation Suites provide full coverage for all of the APIs and services provided by the commercial version of Cs/OS2. Delivered running and tested on your target hardware, each Medical Validation Suite is complete and ready for submission as delivered; for system submission, your system documentation simply references the Validation Suite as part of the delivery. Detailed instructions are provided to integrate the Validation Suite into your project.
The standard Cs/OS2 Medical Validation Suite covers the complete RTOS and port software (hardware abstraction layer). However, VSC can extend your suite to include additional software components such as drivers and application code. Like the standard suite, your enhanced Medical Validation Suite is delivered as a single, convenient, modular, and easy to integrate package.
Our philosophy is to compliment your business, not constrain it. That applies to everything from our licensing to providing support and service after delivery.
You specify the Processor ▪ Target / Developement board ▪ Compiler ▪ Safety Class. We do the rest!Ordering a Validation Suite is easy.
Developed as a complete and self-contained Validation Suiteage for the RTOS components used in an embedded Medical device, VSC’s Medical Validation Suites provide full coverage for all of the APIs and services provided by RTOSes. Validation Suites contain the essential software requirements, design, source code, test code, test results, requirements trace matrix, user’s manual and all other artifacts required to certify popular embedded real-time operating system software.
Delivered running and tested on your target hardware, each Medical Validation Suite is complete and ready for submission as delivered; for system submission, the system documentation simply references the Validation Suite as part of the delivery.
Test Coverage
- 100% Feature/Function coverage
- 100% Statement coverage
- 100% Decision coverage
Validated Software’s Medical Validation Suites are IEC 62304 and FDA 510(k) certifiable and have been used for devices at all levels including Class C/3.
Medical Validation Suite Contents
Documents listed below are a representative sample. Actual documents, names, and their content is subject to change.
- Plans
Software Requirements Specification
Software Safety Validation Plan
Development Plan
Configuration Management Plan
Quality Assurance Plan
Verification Plan
- Standards
Requirements Standard
Coding Standards
Design Standard
- Project Documents and Code
Requirements Document
Design Document
Source Code, Build Code
Test Code and Test Projects
Unit Test Procedures, Plans and Code
Integration Test Procedures, Plans and Code
Tool Qualification Plans
Test Coverage Reports
Trace Matrices
Life Cycle Configuration Index
Configuration Index
Accomplishment Summary
Safety Manual
- Reviews
Document Review Procedure
Document Review Sheets
Code Review Procedure
Code Review Sheets
SQA Checklist
Questions?
Please go to our FAQ page or use our Information Request Form.