Prepare evidence for current QMSR duties

Determine applicability and the current framework

Review the current 21 CFR Part 820 framework, the incorporated ISO 13485:2016 requirements and applicable FDA-specific provisions. Determine the device, establishment and activity scope, including any exemption and its limits. An ISO certificate can be relevant evidence, but it is not an automatic substitute for all applicable FDA requirements or an FDA inspection.

Keep the applicability assessment, process owners, controlled procedures, training and implementation records together. Treat historical Quality System Regulation documents as historical evidence until assessed against the current framework. The free pre-check asks whether readiness has been declared; it does not audit your quality system or certify conformity.

Connect labeling to actual operations

Identify how device specifications, risk controls, supplier changes, production records and labeling revisions are approved and released. Check controls that prevent mixing model versions, expired artwork or incorrect UDI data. Evidence should show that procedures operate in practice, not just that a template exists in a folder.

For example, a packaging change can affect sterile-barrier performance, shelf life, identification and instructions. Route it through the applicable change process and preserve validation and release decisions. Do not count a corrected PDF as sufficient evidence that the manufacturing process and existing inventory now use the correct controlled labeling.

Keep postmarket duties distinct

Review complaints, Medical Device Reporting, corrections or removals and other applicable postmarket processes separately; applicability and reporting deadlines depend on the actual event and role. Record how information reaches the responsible function. This preparation guide does not investigate incidents, calculate a regulatory reporting deadline or submit any notification.

Keep evidence and decisions separate

Keep the original evidence and the released device version together. When a source or fact is uncertain, record the open question instead of converting it into a pass. Official database references and this checklist do not substitute for a device-specific decision.

Official starting points for this topic

• FDA Quality Management System Regulation
• FDA overview of device regulation
• FDA device labeling

FDA page topics were checked on October 7, 2026. Linked regulations and database records still need product-specific applicability review; public links do not establish that a device is authorized.

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