Medical Device Software Validation Procedure Template – QMSR Compatible

QMSR Compatible Software Validation Procedure Template

Any software used in the design, manufacture, or quality system of a medical device must be validated. This Software Validation procedure template provides a risk-based validation framework compatible with QMSR (21 CFR Part 820) and FDA's guidance on software validation (General Principles of Software Validation).

What's Included

• Complete Software Validation procedure compatible with QMSR
• Software categorization and risk-based validation approach
• Validation plan, protocol, and summary report templates
• Change control and revalidation requirements
• Editable in Microsoft Word and Google Docs

Instant digital download. No shipping required.