Record Retention Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 aligned Record Retention Procedure provides guidelines for the retention of all confidential, electronic, quality and archived records and supportive documentation per applicable standards and regulations.

• ISO 13485:2016 aligned

• FDA QMSR aligned

• Includes Retention Period Table

• MS Word Format

• Digital Content - Instant Download

The ISO 13485:2016 aligned Record Retention Procedure provides guidelines for the retention of all confidential, electronic, quality and archived records and supportive documentation per applicable standards and regulations.

Record Retention Procedure Compliance

The Record Retention Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 aligned.

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.