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At FDAInspections.com, we help medical device manufacturers, developers, and suppliers navigate the rigorous FDA inspection process. Whether you’re preparing for a routine Quality System Regulation (QSR) inspection, a Pre-Market Approval (PMA) site inspection, or responding to a FDA-483, our expert support ensures you’re ready to meet FDA expectations with confidence.

Our mission: Empower medical device companies to achieve sustainable FDA compliance, avoid costly enforcement actions, and accelerate market access.

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Why FDA Medical Device Inspections Matter

Medical device inspections are governed by:

• 21 CFR Part 820 – Quality System Regulation (QSR)

• 21 CFR Part 801 – Labeling Requirements

• 21 CFR Part 803 – Medical Device Reporting (MDR)

• 21 CFR Part 806 – Corrections and Removals

• 21 CFR Part 807 – Establishment Registration and Device Listing

Failure to comply can result in:

• FDA Form 483 Observations

• Warning Letters

• Import Alerts

• Consent Decrees

• Product recalls or withdrawal from market

🔗 Learn About Medical Device Regulations (FDA.gov)

Achieving inspection readiness is not optional — it’s essential for survival and growth.

 

Types of Medical Devices We Support

At FDAInspections.com, we work with manufacturers, developers, and distributors across the full range of FDA-regulated medical device types, including:

Class I Medical Devices (Low Risk)

• Bandages, surgical gloves, handheld surgical instruments

• Elastic bandages, manual wheelchairs

• Non-powered breast pumps

Support includes:

• Establishment registration and device listing

• Quality system audits

• Labeling and complaint handling reviews

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Class II Medical Devices (Moderate Risk)

• Powered wheelchairs, infusion pumps

• Blood pressure cuffs, diagnostic imaging devices

• Pregnancy test kits, surgical drapes

Support includes:

• 510(k) submission support and inspection readiness

• Risk management (ISO 14971) implementation

• Supplier controls and CAPA systems

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Class III Medical Devices (High Risk)

• Pacemakers, heart valves

• Implantable defibrillators

• Cochlear implants

Support includes:

• Pre-Market Approval (PMA) inspection preparation

• Design controls and Design History File (DHF) reviews

• Postmarket surveillance program development (MDR compliance)

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Combination Products

• Drug-device combinations (e.g., insulin pumps, prefilled syringes)

• Biologic-device combinations (e.g., vaccine delivery systems)

Support includes:

• Navigating complex regulatory pathways

• Quality systems integration across drug and device requirements

• Inspection readiness for combination manufacturing facilities

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How FDA Inspections .com Helps Medical Device Companies

1. FDA Inspection Readiness Audits for Medical Devices

We perform full-scale mock inspections modeled after FDA QSR audits.

• Quality System Regulation (QSR) audits

• Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) reviews

• Risk Management (ISO 14971) and CAPA evaluations

• Management review and complaint handling assessment

Schedule a Medical Device Readiness Audit

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2. FDA-483 Response and Warning Letter Assistance

If you’ve received a Form 483 or Warning Letter, time is critical. We help:

• Analyze inspection findings

• Draft robust FDA-483 responses and CAPAs

• Prepare supporting documentation

• Provide reinspection preparation services

Get Help With Your FDA-483 Response

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3. Pre-Approval and Pre-Submission Inspection Preparation

We assist companies launching Class II and Class III devices through:

• Pre-Approval Inspections (PAI) preparation

• 510(k) and PMA inspection support

• Regulatory compliance gap assessments

Prepare for Your Device Submission Inspection

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4. Risk Management and Postmarket Compliance

We help you build strong postmarket surveillance programs that satisfy FDA requirements.

• Medical Device Reporting (MDR) systems

• Corrections and Removals reporting

• Field Alert Reports and Recall Strategy planning

Enhance Your Postmarket Compliance

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Common FDA Inspection Focus Areas for Medical Devices

• Design controls and DHF documentation

• Supplier qualification and controls

• Nonconformance handling and CAPA systems

• Complaint handling and Medical Device Reporting (MDR)

• Risk management processes (ISO 14971 alignment)

• Internal auditing programs

• Change control and validation

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Frequently Asked Questions About FDA Medical Device Inspections

Q: What triggers a medical device FDA inspection?
A: Routine surveillance, Pre-Approval Inspections (PAI) for new submissions, and for-cause inspections due to complaints, adverse events, or recalls.

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Q: How often does the FDA inspect medical device companies?
A: Typically every 2–3 years for domestic facilities. Risk-based factors (like past violations or product types) may trigger more frequent inspections.

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Q: How long does it take to prepare for an FDA device inspection?
A: Preparation should be ongoing, but a focused pre-inspection project typically takes 6–12 weeks depending on existing gaps.

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Q: Can FDAInspections.com help with supplier audits too?
A: Yes. Supplier quality management is a major FDA focus area. We perform supplier audits and help build compliant supplier control programs.

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Q: Do you offer international support for FDA inspections?
A: Absolutely. We assist U.S. and international device companies preparing for FDA inspections targeting overseas facilities.