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, IEC 60601, ISO 14971

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 and a collection of sample certification documents are available upon request. To request these PDF samples in zip file format click: Information Request Page.

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. For more information click Medical Validation Suites.