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.
Our logistics operations are built around stringent quality and compliance standards according to MDR, IVDR, ISO 13485, GMP, and GDP requirements, which include:
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:
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:
From hospital deliveries to clinical logistics, we ensure every shipment meets medical-grade quality and documentation standards:
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:
We ensure full end-to-end visibility and regulatory traceability throughout your supply chain:
Beyond warehousing and distribution, we offer specialized services that help you meet project-specific, clinical, or regulatory goals:
WQS combines decades of regulatory experience with modern logistics infrastructure. Our team supports you in maintaining compliance, reducing risk, and ensuring efficient product delivery across the European market.
Let’s talk about how we can optimize your logistics strategy.
Contact us today for a free and non-binding consultation.
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.
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
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.
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
WQS provides you with detailed information on your subject.
You can also explore our FAQ page and other resources for further insight
– or simply contact us for direct support.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
Copyright 2024 WQS Management Consultants GmbH