Jump Start Your Standards Compliance Project with our TemplatesThe 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
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.
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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:
Software Safety Validation Plan
Software Development Plan
Software Configuration Management Plan
Software Quality Assurance Plan
Software Verification Plan
Software Design Standard
Software Requirements Standard
Master Document Template
Plan Review Checklist
Code Review Checklist
Document Review Checklist
Requirements Review Checklist
Verification Review Checklist
Code Review Sheet
Document Review Sheet
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