Specification Format Procedure | ISO 13485 | FDA QMSR
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The Specification Format Procedure establishes consistent document formats across the company.
Areas covered
Document numbering schemes
Headers, footers and body text
Title blocks and drawing dimensions
Document change history
Use the procedure to standardize the presentation and organization of controlled specifications and documents.
Regulatory framework
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
