🇺🇸 Live Medical Devices & Diagnostics

FDA 21 CFR 820 (QSR)

Sets quality system requirements for the design, manufacture, packaging, labeling, storage, and servicing of medical devices. Applies to manufacturers and specification developers of finished medical devices.

View official source document

Rules extracted

211

Obligations decomposed

6.8x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

211

Obligations

6.8x

Decomposition ratio

Each rule is decomposed into an average of 6.8 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 211 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in QSR is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: FDA 21 CFR 820 (QSR)
Regulatory body: FDA Center for Devices and Radiological Health
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: June 1, 1997
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

medical device manufacturerscontract manufacturersspecification developersrepackagers

Key requirements

design controls
document controls
purchasing controls
production and process controls
CAPA system
complaint handling
device history records
management review

Frequently asked questions about QSR

What is QSR?

Who does QSR apply to?

QSR applies to medical device manufacturers, contract manufacturers, specification developers, repackagers.

How many obligations does QSR contain?

AuditDSS has decomposed QSR into 211 atomic obligations from 31 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of QSR?

The key requirements include: design controls, document controls, purchasing controls, production and process controls, CAPA system, complaint handling, device history records, management review.

How can I assess my QSR compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 211 QSR obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces QSR?

QSR is enforced in United States by FDA Center for Devices and Radiological Health.

When did QSR come into effect?

QSR became effective on June 1, 1997.

What industry does QSR apply to?

QSR is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a QSR compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for QSR — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering QSR requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

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Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 211 obligations

Your document is scored against every obligation in QSR. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.