Storage & Fulfillment for Medical Devices
Your Trusted Medical Device 3PL Partner
When it comes to Medical Devices and In-vitro Diagnostics, logistics are far more than just warehousing and shipping. For manufacturers, distributors and importers of regulated products, storage and fulfillment must adhere to strict regulatory, quality and safety standards.
WQS offers comprehensive third-party logistics (3PL) solutions tailored to the needs of Medical Device and IVD Manufacturers. With a strong presence in both the US and the EU, we provide certified storage, fulfillment and distribution services, that are built to ensure full regulatory compliance, risk mitigation and operational efficiency across the entire supply chain.
Regulatory & Quality Compliance
Our logistics operations are built around stringent quality and compliance standards according to MDR, IVDR, ISO 13485, GMP, and GDP requirements, which include:
- Certified ISO 13485:2016 Quality Management System
- GDP/GMP-compliant warehousing and handling procedures
- MDR & IVDR-aligned logistics workflows
- Validated SOPs, change control, deviation management and CAPA systems
- Full audit readiness – internal, customer, notified body, FDA
Medical Device Warehousing & Controlled Storage
Our warehousing solutions are equipped to store sensitive and high-value products safely and in compliance with regulatory expectations to support product integrity, environmental stability and risk mitigation:
- Controlled environments: ambient (15–25 °C) and cold chain (2–8 °C) storage
- Real-time environmental monitoring and alarm systems
- Calibrated temperature sensors and periodic mapping
- Segregated zones for quarantine, hazardous, or high-value goods
- Cleanroom-ready handling (where applicable) and pest control protocols
Inventory Management & UDI Tracking
We maintain full visibility and control over your inventory – from batch traceability to regulatory data integrity, we ensure you have complete oversight of your stock at all times:
- Batch/lot and serial number tracking
- Support and Integration of Unique Device Identification (UDI)
- Expiry date monitoring and First-Expire, First-Out (FEFO) management
- Vendor Managed Inventory (VMI) and consignment stock options
- Real-time inventory access via client portal or integration (API/EDI)
Medical Device Fulfillment & Distribution
From hospital deliveries to clinical logistics, we ensure every shipment meets medical-grade quality and documentation standards:
- B2B, clinic, hospital and e-commerce order fulfillment
- Regulatory-compliant labeling and secondary packaging
- Tamper-evident seals, sterility safeguards and IFU insertion
- EU shipping with GDP-compliant carriers
- Customs clearance, documentation and HS classification
Returns & Reverse Medical Device Logistics
Handling returns in the medical sector is a regulated, sensitive process. We offer a structured and fully documented reverse logistics system that ensures safety, traceability and regulatory compliance:
- Returns inspection and triage
- Quarantine and non-conformance management (NCMR)
- Repackaging, relabeling and re-sterilization
- Safe disposal or certified destruction with documentation
System Integration & Traceability
We ensure full end-to-end visibility and regulatory traceability throughout your supply chain:
- Validated Warehouse Management System (WMS) with audit trails
- Integration with your ERP or Track & Trace system (API, EDI)
- Optional 21 CFR Part 11 compatibility with digital signatures and access control
- Full chain-of-custody documentation for every transaction
Value-Added Services
Beyond warehousing and distribution, we offer specialized services that help you meet project-specific, clinical, or regulatory goals:
- Clinical trial supply and distribution
- Kit assembly and custom configurations
- Localization of labels and Instructions for Use (IFUs)
- Product recall management
- KPI reporting and supply chain analytics
Our Warehouse Locations
EU-Location
Hamm, Germany
- MDR- and IVDR-compliant processes
- ISO 13485-certified QMS
- GDP-compliant EU shipping
- Direct access to the European market
- Notified Body audit-ready
U.S.-Location
St. Petersburg, Florida
- QMSR (21 CFR Part 820)-aligned processes
- FDA US Agent Service available
- 21 CFR Part 11 option for digital records
- Coordination with EU location for transatlantic supply chains
Storage • Fulfillment
Request Storage Capacity
WQS combines decades of regulatory experience with modern logistics infrastructure.
Our team supports you in maintaining compliance, reducing risk, and ensuring efficient product delivery.
Frequently Asked Questions
What makes Medical Device logistics different from standard logistics?
Logistics for Medical Devices and IVDs must comply with strict regulatory and quality standards (e.g., MDR, IVDR, ISO 13485, GDP). Unlike general logistics, medical device fulfillment requires controlled environments, traceability and documented procedures to ensure patient safety and product performance.
What storage conditions are available for Medical Devices?
We offer various services, including:
• Ambient storage (15–25 °C) and cold chain storage (2–8 °C)
• Real-time environmental monitoring and alarm systems
• Calibrated temperature sensors and periodic mapping
• Segregated zones for quarantine, high-value, or hazardous goods
• Cleanroom-ready handling (where applicable) and pest control protocols
How is traceability ensured for inventory and shipments?
We provide batch/lot and serial number tracking, support UDI integration and monitor expiry dates using a validated WMS. Our systems offer real-time access and API/EDI integration with your ERP for end-to-end traceability.
What happens when a Medical Device needs to be returned or recalled?
Our reverse logistics services include:
• Returns inspection and triage
• Quarantine and NCMR handling
• Repackaging, relabeling, and re-sterilization
• Certified destruction and documentation for unsafe or expired goods
References
- European Parliament & Council of the EU: Regulation (EU) 2017/745 on Medical Devices (MDR), Official Journal of the European Union, May 5, 2017 – eur-lex.europa.eu
- DIN Media: DIN EN ISO 13485 (standard available for a fee) – dinmedia.de
- FDA U.S. Food & Drug Administration: Quality Management System Regulation (QMSR) – fda.gov
