CFR 21 Part 820 (QSR) Internal Auditing Services
Our CFR 21 Part 820 Internal Auditing services support medical device manufacturers in ensuring compliance with FDA Quality System Regulation (QSR) requirements. Patient Guard provides independent, expert audits to help you identify gaps, reduce regulatory risk, and maintain inspection readiness.
CFR 21 Part 820 (QSR) Internal Auditing Services
Medical device manufacturers distributing products in the United States must comply with the FDA’s Quality System Regulation (21 CFR Part 820).
Internal audits are a critical component of maintaining compliance, ensuring that your Quality Management System (QMS) is effectively implemented and aligned with FDA requirements.
Patient Guard provides professional CFR 21 Part 820 internal auditing services, delivering an independent and objective review of your QMS against FDA expectations.
We help organisations prepare for FDA inspections, identify compliance gaps, and strengthen quality system processes.
Whether preparing for an FDA inspection or maintaining ongoing compliance, we ensure your QMS is audit-ready and aligned with regulatory requirements.
Why Choose Patient Guard for QSR Internal Auditing?
Independent & Objective Reviews
Outsourcing your internal audits to our specialists guarantees absolute objectivity. We provide the strict, unbiased oversight needed to catch hidden systemic gaps before an investigator does.
FDA Inspection-Focused Lens
We do not treat audits as a mere box-ticking chore. Our team replicates authentic FDA investigator mindsets and QSIT approaches, testing the true real-world pressure tolerance of your quality processes.
Clear & Actionable Outcomes
We deliver comprehensive, straightforward audit reports paired with pragmatic, compliance-focused recommendations. You receive a structured roadmap to quickly eliminate risks with zero guesswork.
Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.”
Tracey Slater, Cormed
What Our CFR 21 Part 820 Internal Auditing Service Includes
Full 21 CFR Part 820 Audits
We perform comprehensive, top-to-bottom evaluations of your entire Quality Management System to ensure unbroken alignment with mandatory FDA Quality System Regulations.
Deep Subsystem Evaluations
We target critical high-stakes operational subsystems, deeply reviewing your Design Controls, CAPA trails, Production and Process Controls, and Supplier Management protocols.
Rigorous Documentation Reviews
Our auditors meticulously review standard operating procedures, history records, and device master records to verify full data traceability and complete FDA audit readiness.
Nonconformity Gap Identification
We pinpoint procedural weaknesses and regulatory gaps early, mapping them out clearly so you can implement robust corrective actions well before an official facility inspection.
Inspection Readiness & Support
We coach and prepare your internal personnel, ensuring your subject matter experts understand how to communicate with investigators confidently during live audit interviews.
Who Requires CFR 21 Part 820 Internal Auditing?
- Medical device manufacturers selling in the United States
- Organisations preparing for FDA inspections
- Companies maintaining FDA QSR compliance
- Start-ups entering the US medical device market
FDA QSR (21 CFR Part 820) Requirements
Under 21 CFR Part 820, manufacturers must establish and maintain a quality system that ensures products consistently meet regulatory and safety requirements.
Internal audits are expected to:
- Verify compliance with QSR requirements
- Ensure procedures are effectively implemented
- Identify quality system gaps
- Support corrective and preventive actions (CAPA)
- Maintain inspection readiness
Our Process
Audit planning
We define scope, schedule, and audit objectives.
Audit execution
We conduct the audit, including interviews, document review, and process assessment.
Reporting
We provide findings, identify non-conformities, and support corrective actions.
Areas we assess
We assess all key areas of your QMS, including:
- Design controls
- Corrective and Preventive Actions (CAPA)
- Document and record control
- Production and process controls
- Supplier management
- Complaint handling and vigilance
- Training and personnel competence
Cost of Service
CFR 21 Part 820 QSR Internal Auditing
From
Ensure ongoing compliance and Inspection readiness with expert CFR21 Part 820 quality Internal audits.
Audit Costs
- Small Size Organisation (<10 employees) 2 day audit £2,000
- Medium Size Organisation (10-50 employees) 3 day audit £3,000
- Large Size Organisation (>50 employees) 4 day audit £4,000
Time Lines
Planning
1-2 weeks
Audit
2-4 days depending on organisation size
Reporting
2-4 days depending on organisation size
Frequently Asked Questions (FAQs)
What is a CFR 21 Part 820 internal audit?
A CFR 21 Part 820 internal audit is a systematic review of a manufacturer’s Quality Management System to ensure compliance with FDA Quality System Regulation requirements.
Are internal audits required under FDA QSR?
While not explicitly labelled the same as ISO standards, internal audits are expected as part of maintaining an effective quality system and ensuring ongoing compliance.
Can internal audits be outsourced?
Yes, outsourcing internal audits ensures independence, objectivity, and access to experienced FDA regulatory experts.
How often should QSR audits be conducted?
Audits should be conducted at planned intervals, typically annually or more frequently depending on risk and organisational complexity.
How long does a QSR internal audit take?
The duration depends on the size and complexity of your QMS but typically ranges from 2–5 days.
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