FDA Compliant Medical Equipment Shipping
21 CFR-Aligned Transport with Full Chain-of-Custody Documentation
Moving FDA-regulated medical devices — from Class I instruments to Class III implantable devices and capital imaging equipment — requires strict adherence to FDA Quality System Regulations (21 CFR Part 820) and Good Manufacturing Practices (GMP). Our logistics team is trained in FDA-compliant shipping protocols and provides the documentation, chain-of-custody records, and controlled transport conditions required for regulated medical device movement.
What's Included
Our Process
How It Works
Regulatory Assessment
We review the FDA classification and specific regulatory requirements for your device to establish the appropriate transport protocol.
Quality Documentation Setup
Before the move, we establish all required documentation — work orders, chain-of-custody forms, temperature logs, and deviation procedures.
Controlled Packaging
Devices are packaged in GMP-compliant materials with proper labeling including device ID, lot number, storage conditions, and handling warnings.
Monitored Transport
Data loggers record temperature, humidity, and shock throughout transit. Calibrated instruments provide an unbroken environmental audit trail.
Receipt Verification
On delivery, our team completes a formal receiving inspection comparing shipped condition against receipt condition for immediate deviation reporting.
Documentation Package
You receive a complete documentation package including all manifests, temperature logs, chain-of-custody records, and deviation reports if any occurred.
FAQ
Frequently Asked Questions
Are you familiar with 21 CFR Part 820 requirements?
Yes. Our team is trained in FDA Quality System Regulation requirements and we align our logistics documentation with the controls expected in your QMS.
Do you provide IQ/OQ documentation support?
We support the Installation Qualification phase by providing pre-delivery condition documentation that can feed into your IQ records. We coordinate with your validation team.
Can you transport active implantable medical devices?
Yes. Class III active implantable devices require the strictest handling. We have controlled-environment vehicles and trained handlers for these high-risk items.
What if there's a temperature excursion during transport?
Our data loggers immediately flag any excursion. We follow a formal deviation process, document the event, and work with your quality team to determine product disposition.
Do you have experience with FDA enforcement actions or audits?
Our documentation is designed to be audit-ready. We can provide records in a format that supports your response to any FDA inspection or 483 observation.