Medical Validation Templates for Certification

Jump Start Your Standards Compliance Project

The standards compliant Validation Templates™ pack includes all documents, plans, standards, checklists, review notes and project plans, ready to be easily customized to your requirements.

FDA 510(k) ▪ IEC 62304

The Medical Validation Template Pack was created to aid both experienced and novice developers in creating and submitting their software for certification to the highest rigors of medical safety standards such as IEC FDA certification of all classes of medical devices. The Templates were created for both new development and retrofitting legacy applications to applicable standards

More than a simple “Document Set,” Validation Templates are derived from successfully submitted and certified software projects. Provided in Microsoft Office Word format, all components are completely customizable and provide all of the plans, standards, checklists, review notes and project plans that you will need for certification.

Easy to use and understand Validation Templates contain comprehensive samples, examples a detailed User Manual. When used in conjunction with IEC, ISO, or FDA the Medical Validation Template Pack permits rapid integration of a certification compliant process, whether for a new or existing product or company.

Since their introduction, Medical Validation Templates have been used successfully in numerous embedded medical devices requiring formal certification.

Medical Validation Template Pack Contents

Documents listed below are a representative sample. Actual documents, names, and their content is subject to change.

  • Plan Templates
    Safety Validation Plan
    Development Plan
    Maintenance Plan
    Verification Plan

  • Standards
    Configuration Management Plan
    Quality Assurance Plan
    Requirements Standard
    Coding Standards
    Design Standard

  • Project Templates and Code
    Requirements Specification
    Requirements Document
    Design Document
    Unit Test Procedures, Plans, Reports
    Integration Test Procedures, Plans, Reports
    Tool Qualification Plans
    Test Coverage Report
    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 Checklists



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Medical Quick Links

Medical Validation Products

Validation Suites
Micrium µC/OS RTOS
ExpressLogic ThreadX

Validation Kits
Micrium µC/OS RTOS

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