Medical Validation Templates for Certification

Jump Start Your Standards Compliance Project with our Templates

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/CDRH 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/CDRH 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/CDRH 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,  Industrial Validation Templates have been used successfully in numerous embedded medical devices requiring formal certification.

A sampling of the list of documents provided appears in the right hand column, under the heading "Medical Validation Template Pack Contents" 

Additional information isare available upon request. To request samples click: Information Request Page.

Need a custom I/O driver?

VSC offers a wide range of customizable Portable Driver packages with full certification artifacts. 
Click here for more info .

As always, if your plans call for complete test independence, Validated Software Corporation can provide full Validation Suites run on your hardware at our test facilities.

Medical Validation Templates Pack Contents

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

Template Packs contain all necessary Plans, Standards, Checklists, Review Notes, and Project Documents, with titles like:

Plans
Software Safety Validation Plan
Software Development Plan
Software Configuration Management Plan
Software Quality Assurance Plan
Software Verification Plan

Standards
Coding Standards
Software Design Standard
Software Requirements Standard
Master Document Template

Checklists
Project Checklist
Plan Review Checklist
Code Review Checklist
Document Review Checklist
Requirements Review Checklist
Verification Review Checklist

Review Notes
Code Review Sheet
Document Review Sheet

Project
Software Safety Requirements Specification
Port Software Requirements Document
Port Software Design Document
Software Unit Test Plan
Software Unit Test Procedure
Software Unit Test Results
Software Integration Test Plan
Software Integration Test Procedure
Software Integration Test Results
Software Configuration Index
Software Correlation Matrix
Software Accomplishments Summary
Safety Manual

 

     

 

Medical Links

Medical Certification Solutions Overview

Medical Validation Suites
Medical Suites for Micrium
Medical Suites for ExpressLogic

Medical Validation Kits
Medical Kits for Micrium  

For any Medical Software
Medical Validation Templates

Time and Space Partitioned RTOS
Valid-653 / Rapid-653

Medical FAQ

Medical Resources

 

Need more information?

Use our: Information Request Form

E-mail: info@ValidatedSoftware.com

Phone: 1-760-448-5391