Medical Device Fulfillment
Built for Compliance
Medical device fulfillment is the process of storing, picking, packing, and shipping FDA-regulated medical devices (Class I-III) with serial-number tracking, lot-level traceability for recalls, sterile-condition storage where required, and full 21 CFR Part 820 documentation. We operate from 250,000 sq ft in Paramount, CA.
FDA
Registered Facility
>99%
Lot Accuracy
0
FDA Findings
UDI: (01)00884567001234
COLD CHAIN
FDA
REGISTERED
ISO 13485
Certified
21 CFR 820
Compliant
QMS Dashboard
Real-time
Lots Today
0
Compliance
0%
RECENT ACTIVITY
Built for Medical
Device Excellence
Our purpose-built infrastructure and trained staff handle your medical devices with the precision and compliance your industry demands.
Regulatory Compliance
Full FDA 21 CFR Part 820 compliance with documented quality management systems. We maintain ISO 13485 certification and handle all device classes.
Full Traceability
Complete lot and batch tracking with UDI compliance. Every device is traceable from receipt through delivery, supporting recall management.
Controlled Storage
Temperature and humidity-controlled environments for sensitive devices. Sterile storage areas available for implantables and surgical devices.
Specialized Shipping
Cold chain logistics and validated shipping for temperature-sensitive devices. Signature verification and chain of custody documentation.
We Handle All Device Classes
From low-risk Class I to life-sustaining Class III devices, we have the expertise.
Class I
Low RiskLow-risk devices like bandages, exam gloves, and tongue depressors
Class II
Moderate RiskModerate-risk devices requiring special controls and performance standards
Class III
High RiskHigh-risk devices that sustain life or present potential unreasonable risk
From Receipt to
Compliant Delivery
Every step of our medical device fulfillment process is designed for regulatory compliance and audit readiness.
Compliant Receiving
Every device undergoes rigorous inspection with full documentation of lot numbers, UDI data, and condition verification.
Controlled Storage
Devices are stored in appropriate environmental zones with continuous monitoring and documented chain of custody.
Order Processing
Precision picking with double verification, sterile handling protocols, and complete order accuracy documentation.
Validated Shipping
Temperature-validated packaging, carrier selection based on device requirements, and complete chain of custody documentation.
Ready to experience compliance-first fulfillment?
Request Compliance AssessmentBuilt for Regulatory
Excellence
Our medical device fulfillment infrastructure exceeds industry standards for compliance, traceability, and quality management.
Lot Traceability
Complete chain of custody
FDA Audit Ready
Documentation on demand
Temperature Monitoring
Real-time environmental control
Recall Response
Average notification time
Quality Management
Full regulatory compliance across all FDA requirements and ISO standards.
FDA Registered
21 CFR 820
ISO 13485
Certified
HIPAA
Compliant
UDI
Enabled
Quality Performance Indicators
All Systems Operational
Environmental controls within spec • Last check: 2 min ago
Medical Device
Categories We Handle
We handle FDA-regulated medical device fulfillment from our 250,000 sq ft Paramount, CA facility — diagnostic, surgical, implantable, and monitoring equipment with full lot tracking and compliant storage.
Medical Device Categories We Fulfill
Compliance Questions Answered
Get answers to common questions about our medical device fulfillment capabilities and regulatory compliance.
Yes, our facility is FDA registered and fully compliant with 21 CFR Part 820 (Quality System Regulation). We maintain documented procedures for device handling, storage, and distribution that meet FDA requirements. Our quality management system is audited regularly and we provide full documentation for your regulatory submissions.
Need a Compliance Consultation?
Our regulatory specialists can review your device requirements and create a custom fulfillment plan.
Get started with 3PLGuys today
Ready to explore 3PLGuys? Request a demo today!