Software Validation Procedure | ISO 13485 | FDA QSR Compliant
SKU: SOP 7-033
The ISO 13485 Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities, to ensure the software has been validated for the intended use.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
ISO 13485 Software Validation Procedure
The ISO 13485 Software Validation Procedure establishes the requirements for computer systems and software used in medical device development, production and post-distribution QA activities to ensure they have been validated for their intended use.
Software Validation Procedure Overview
The ISO 13485 Software Validation Procedure uses a risk based approach to conducting software validations. The ISO 13485 Software Validation Procedure includes a detailed protocol/report form that can be adopted for different types of software and aligned with a particular function.
Software Validation Procedure Compliance
The ISO 13485 Software Validation Procedure is FDA QSR and ISO 13485:2016 compliant.
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