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
Questions?
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