Software Validation Procedure | ISO 13485 | FDA QSR Compliant

SKU: SOP 7-033
$149.00
$149.00
Unavailable
per item
The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The procedure includes a detailed validation protocol with step by step instruction for conducting the validation and generating a validation report.
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download

ISO 13485 Software Validation Procedure

The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The protocol, included with the procedure, can be applied to the validation of computer systems, software used in medical device development, production, testing and inspection activities, and more to ensure each has been validated for their intended use.​

ISO 13485 Software Validation Procedure Overview

The Software Validation Procedure uses a risk based approach for conducting software validations. The validation protocol included with the procedure provides step by step instruction through the entire validation process. The procedure also provides instruction on the content and structure of validation reports.

Software Validation Procedure Compliance

The Software Validation Procedure is FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
To learn more about our Software Validation Procedure contact us at info@aplyon.com

RELATED LINKS

Medical Device Software Procedure Bundle
​Medical Device Quality Management System DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Software Validation Procedure
Software Validation Procedure

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